What was recalled
The U.S. Food and Drug Administration (FDA) has issued a Class II recall involving specific medical equipment manufactured by IMRIS Imaging Inc. This action targets the ORT300 operating room table, a critical piece of hardware used in surgical settings to position patients during procedures. Specifically, the recall focuses on the "ORT300 Modular Table Main Unit Assy," which serves as the foundational base and control mechanism for the table’s movement capabilities. It is important to note that this is not a blanket recall of every ORT300 table ever produced; rather, it is strictly limited to units equipped with particular main assembly components that have been identified as potentially defective.
The affected products are defined by two distinct part numbers: 114093-000 and 114093-600. These part numbers identify the specific Modular Table Main Unit Assy configurations that contain the problematic linear actuator and rotational lock mechanism components. For healthcare facilities attempting to verify their inventory, precise identification is key. The recall details provide Unique Device Identification (UDI) Data Identifiers to help distinguish these units. Units with part number 114093-000 carry the UDI-DI 00857534006356, while units with part number 114093-600 carry the UDI-DI 00857534006462. These identifiers are crucial for hospital supply chains and biomedical engineering teams to quickly audit their stock.
The scope of the affected inventory includes specific serial numbers associated with each part number. For the 114093-000 assembly, the recalled serial numbers are 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, and 10011119. For the 114093-600 assembly, the affected serial numbers are 10002996, 10004515, 10007411, and 10007376. While the recall notice does not explicitly state the total quantity of units sold, it confirms that these devices were part of a worldwide distribution pattern. This means they were not only available throughout the United States but were also distributed to international markets, including Canada, China, Japan, and Sweden.
The recall was officially initiated on August 6, 2026. Although the FDA classifies this as a Class II recall, which typically indicates a situation where use of the product may cause temporary health problems or pose a slight threat of serious harm, it remains a serious matter for surgical teams. The fact that these tables were distributed globally underscores the importance of IMRIS Imaging and healthcare providers in all affected countries checking their equipment logs immediately. If you are a biomedical engineer or facility manager handling an ORT300 table, cross-referencing the serial numbers on your unit’s nameplate against the list above is the first step in determining if your specific device is included in this safety action.
The hazard, explained
Understanding why this recall matters requires looking closely at the mechanical heart of the ORT300 operating room table: specifically, the linear actuator and the rotational lock mechanism. In simple terms, these components work together to hold the patient securely in place while allowing medical staff to adjust the table’s position with precision. The linear actuator is responsible for moving parts along a straight path, while the rotational lock ensures that sections of the table remain firmly locked at a specific angle or orientation once positioned. Together, they create a stable platform essential for delicate surgical procedures.
The core issue identified by the FDA and IMRIS Imaging Inc. is a potential mechanical failure within these specific components. This failure disrupts the system’s ability to transition smoothly and reliably between its locked and unlocked states. Imagine trying to lock a door that has a broken latch; it might appear secure, but it lacks the internal integrity to hold fast under pressure. In the context of this operating room table, the mechanism may fail to engage properly or, more dangerously, may disengage unexpectedly. This loss of mechanical control means the table can no longer guarantee the stability it was designed to provide.
The primary risk arising from this failure is unintended rotational movement. During a procedure, surgeons and medical teams rely on the absolute stillness of the operating table to perform intricate tasks. If the rotational lock fails while a patient is positioned on the table, the surface may shift or rotate without warning. This is not merely an inconvenience; it is a significant safety hazard. Unplanned movement can disrupt sterile fields, interfere with surgical instruments, and most critically, cause physical injury to the patient. A sudden shift could lead to falls, strains, or other trauma, particularly if the patient is under anesthesia or otherwise unable to brace themselves against the movement.
This type of mechanical failure highlights a broader concern in medical device engineering: the critical importance of redundancy and reliability in load-bearing and positioning systems. When a component like a rotational lock fails, it removes a layer of safety that surgeons depend on implicitly. While the recall notice does not specify whether the failure occurs during setup or mid-procedure, the implication is clear: the integrity of the patient’s position cannot be trusted. This uncertainty forces medical facilities to exercise extreme caution, potentially halting procedures or requiring manual stabilization measures that add complexity and risk to an already high-stakes environment. Understanding this mechanism helps clarify why the FDA has classified this as a Class II recall, indicating a moderate to serious potential for injury if the defect is not addressed promptly.
Who is most at risk
To understand who is truly at risk with this recall, we first need to look at the specific nature of the device involved. The IMRIS Imaging ORT300 is not a consumer product found in homes or local hardware stores; it is a specialized operating room table designed for use in professional medical settings. Consequently, the primary group of individuals directly exposed to this hazard are patients who undergo surgical or diagnostic procedures that require this specific modular table system. The risk is not widespread across the general public but is concentrated entirely within clinical environments where these tables are installed and operated by trained medical staff.
The core of the danger lies in the mechanical failure of the linear actuator and rotational lock mechanism. When these components fail, the table may become stuck between locked and unlocked states, or worse, allow unintended rotational movement while a patient is positioned on it. This creates a scenario where the stability of the patient’s position can no longer be guaranteed by the equipment itself. Therefore, the individuals most vulnerable to injury are those who are already in a compromised physical state due to the medical procedure they are undergoing. During surgery or complex diagnostic imaging, patients are often under anesthesia, sedation, or heavy pain management. In these states, they are completely passive and unable to adjust their position or signal distress if the table shifts unexpectedly.
Among patient populations, certain groups face heightened vulnerability depending on the type of procedure being performed. For instance, elderly patients or those with pre-existing musculoskeletal conditions, such as osteoporosis or severe arthritis, are at greater risk for injury from even minor, unintended movements. If the table rotates unexpectedly during a sensitive procedure, the torque applied to their joints or spine could cause fractures, soft tissue damage, or nerve compression that might not occur in a healthier individual. Similarly, patients undergoing neurosurgery or orthopedic procedures often require extreme precision and immobility; any mechanical instability in the support structure can compromise the surgical outcome or lead to positional injuries.
It is also important to recognize that while the patient bears the physical risk, the medical team operating the table shares the burden of safety. Surgeons, nurses, and technicians rely on the equipment’s reliability to maintain a sterile field and ensure patient alignment. A mechanical failure during a critical phase of an operation forces the medical staff to halt their work, potentially complicating the procedure and increasing stress in an already high-stakes environment. While the recall notice does not specify incidents involving injury, the potential for harm is inherently tied to the interaction between the failing mechanism and the patient’s body during these vulnerable moments.
In summary, the people most at risk are patients currently using or scheduled to use the ORT300 Modular Table Main Unit in operating rooms across the United States, Canada, China, Japan, and Sweden. The vulnerability is not based on age or demographic alone but on the context of medical intervention, where loss of motor control and reliance on equipment stability are paramount. If you or a loved one is scheduled for surgery involving this specific table, it is crucial to verify whether the facility has addressed this recall before proceeding.
How to tell if you have the recalled item
If you are a medical facility administrator, biomedical engineer, or clinical staff member working in an operating room environment, verifying whether your equipment is part of this specific FDA recall requires careful attention to detail. Because the ORT300 Modular Table Main Unit Assy is a specialized piece of heavy medical infrastructure rather than a consumer good sold in retail stores, you likely will not find it on a receipt from a typical retailer. Instead, your primary method of identification will be the physical hardware itself and the associated documentation that came with the installation. The recall issued by IMRIS Imaging specifically targets two distinct part numbers for the ORT300 operating room table: Part Number 114093-000 and Part Number 114093-600. If your facility’s equipment logs list either of these part numbers, you must proceed to verify the serial numbers or Unique Device Identifiers (UDI) to confirm if your specific unit is affected.
The most reliable way to identify the recalled devices is by locating the official identification labels attached directly to the hardware. For units bearing Part Number 114093-000, you need to look for the UDI-DI code 00857534006356. This specific identifier is crucial because it links the physical table to the regulatory record. If your unit has this UDI-DI, you must then cross-reference the serial number against the list of affected units provided by the agency. The recalled serial numbers for Part Number 114093-000 are 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, and 10011119. It is important to note that if your unit has Part Number 114093-000 but a serial number not listed above, it is not part of this specific recall batch. Similarly, for units with Part Number 114093-600, you must look for the UDI-DI code 00857534006462. The affected serial numbers for this configuration are 10002996, 10004515, 10007411, and 10007376.
Why does this level of specificity matter? In medical settings, equipment is often customized or upgraded over time. A table might have been modified with different components, meaning the base model name remains the same (ORT300), but the specific assembly part number changes. Therefore, checking the brand name "IMRIS Imaging" alone is not sufficient to determine eligibility for the recall. You must confirm the exact part number and match it with either the correct UDI-DI or one of the listed serial numbers. These devices have been distributed worldwide, including throughout the United States, Canada, China, Japan, and Sweden, so geographic location does not rule out the possibility that your facility holds a recalled unit. If you are unable to locate the physical labels on the table due to wear or removal during previous maintenance, consult your facility’s biomedical equipment management system or contact IMRIS Imaging directly for assistance in locating these records based on purchase dates or installation reports.
When conducting this check, ensure that you are looking at the main unit assembly. The recall pertains specifically to the ORT300 Modular Table Main Unit Assy. Other components of the operating room table system that may have been installed alongside it but do not carry these specific part numbers are not included in this action. If you confirm that your unit matches one of the part numbers and has a listed serial number or UDI-DI, treat the equipment as potentially unsafe for patient use until further notice. Do not attempt to repair the linear actuator or rotational lock mechanism yourself, as improper handling could exacerbate the mechanical failure risk. Instead, document your findings clearly and prepare to contact the manufacturer or follow the official remedy instructions once they are released by the FDA.
What to do — step by step
If you or your medical facility are in possession of the recalled IMRIS Imaging ORT300 Modular Table Main Unit Assy, specifically those with Part Numbers 114093-000 and 114093-600, taking immediate and careful action is essential for patient safety. The primary concern here involves a mechanical failure in the linear actuator and rotational lock mechanism, which could allow unintended movement during critical procedures. Because the official remedy details have not yet been stated by the FDA or IMRIS Imaging, you must proceed with caution and prioritize communication over assumption. Do not attempt to repair, disassemble, or modify the device yourself, as this could void warranties, complicate future remediation efforts, or create additional safety hazards.
First, you must verify exactly which unit you have by checking the identification labels on the table’s main assembly. Look closely for Part Number 114093-000 or 114093-600. If you have the 114093-000 model, confirm that your serial number matches one of the following: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, or 10011119. If you have the 114093-600 model, check if your serial number is 10002996, 10004515, 10007411, or 10007376. You can also cross-reference these parts with their Unique Device Identifiers (UDI-DI): 00857534006356 for the first part number and 00857534006462 for the second. This verification step is crucial because the recall is limited to specific batches, and you do not want to disrupt operations unnecessarily if your unit is safe.
Once you have confirmed that your device is among those affected, stop using the table for patient procedures immediately. The risk of unintended rotational movement poses a direct threat to patient stability and surgical precision, so continued use is not an option until further notice. Next, contact IMRIS Imaging or the relevant FDA recall coordinator right away. Since the specific remedy—whether it involves a return, a repair kit, a software update, or a full replacement—is not yet stated in the current recall notice, you need official guidance to know exactly how to proceed. Keep a record of your communication, including dates, names of representatives spoken to, and any case numbers provided.
In the meantime, ensure that your facility’s maintenance team is aware of the status so they can tag the device as “out of service” or “do not use” in your inventory management systems. This prevents accidental reactivation by staff who may not be aware of the recall. If you are a patient who was recently treated on one of these tables, monitor yourself for any unusual symptoms related to positioning or stability during your procedure and consult your healthcare provider if you have concerns. Remember, while general safety tips suggest reporting adverse events to the FDA’s MedWatch program, the immediate priority is securing official instructions from the manufacturer regarding the next steps for your specific unit.
Your refund, repair, or replacement options
When you encounter a product recall, the most immediate question is often, "What happens next?" and "How do I get my money back or a working device?" In this specific instance involving IMRIS Imaging’s ORT300 operating room table, it is important to approach the situation with patience and clarity. The official FDA recall documentation, dated August 6, 2026, does not explicitly state the remedy in terms of financial compensation, direct replacement units, or repair instructions. While this absence of specific remedial details might feel unsettling, it is a known occurrence in certain Class II device recalls where the manufacturer is still finalizing logistical protocols or where the primary immediate action is identification and cessation of use rather than an automated exchange.
Because the recall facts do not provide a direct refund portal, a prepaid shipping label for return, or a specific repair timeline, you should not assume that standard consumer retail return policies apply here. Medical devices like the ORT300 are highly specialized pieces of equipment distributed through complex B2B (business-to-business) channels rather than direct-to-consumer storefronts. Consequently, the "options" available to you are likely tied to your original contract with IMRIS Imaging or your facility’s procurement department. If you are a hospital administrator, biomedical engineer, or healthcare provider who purchased these units directly from IMRIS Imaging or an authorized distributor, your first step is to locate your original purchase order and serial number documentation.
For owners of the ORT300 Modular Table Main Unit Assy with Part Numbers 114093-000 and 114093-600, the remedy phase will likely involve contacting IMRIS Imaging directly to initiate a service request. Since the recall is classified as Class II, which indicates a moderate risk of serious injury if the device fails, the manufacturer is legally obligated to correct the hazard. This correction may take several forms that are not yet detailed in the public summary: it could involve an on-site technician visiting your facility to replace the faulty linear actuator and rotational lock mechanism components; it might involve shipping you a refurbished main unit assembly; or it could result in a credit against future service contracts or a partial refund if the device is deemed unsalvageable. You will need to wait for IMRIS Imaging to release specific instructions regarding how to proceed with these corrective actions.
In the meantime, do not attempt to repair the device yourself. The hazard involves mechanical failure of critical safety components that prevent the system from transitioning between locked and unlocked states. Attempting unauthorized repairs could void any warranty protections and exacerbate the risk of unintended rotational movement during a procedure. Instead, document your ownership by recording the UDI-DI numbers (00857534006356 for part 114093-000 and 00857534006462 for part 114093-600) and the specific serial numbers listed in the recall notice. When you eventually contact IMRIS Imaging to inquire about your specific remedy options, having this precise identification data will expedite the process. Whether you are in the United States, Canada, China, Japan, Sweden, or elsewhere with worldwide distribution, the resolution will be managed through official manufacturer channels rather than through third-party retailers.
What can happen if you ignore it
When a recall involves medical equipment used in high-stakes environments like an operating room, the consequences of inaction are rarely abstract. They are immediate, physical, and potentially life-altering. In the case of the IMRIS Imaging ORT300 Modular Table Main Unit, the core issue lies in the mechanical integrity of the linear actuator and rotational lock mechanism. These components are not merely convenience features; they are the primary safety anchors that hold a patient securely in place during delicate surgical procedures. If you continue to use this equipment without addressing the recall, you are effectively relying on a failing safety system that has already demonstrated a propensity for unexpected failure.
The specific danger here is unintended rotational movement. Under normal circumstances, when a surgeon or nurse engages the locking mechanism, the table should remain rigid and immobile relative to its base. However, because the recalled units may fail to transition correctly between locked and unlocked states, the table could shift unexpectedly. Imagine a patient lying supine on the table during a procedure that requires millimeter-level precision, such as neurosurgery or orthopedic alignment. If the rotational lock fails while the system is supposed to be stable, the surface beneath the patient can twist or rotate against their will. This is not a minor wobble; it is a loss of positional control.
The direct consequence of this mechanical failure is significant risk of physical injury to the patient. Unintended movement can cause shearing forces on the skin and underlying tissues, leading to bruising, lacerations, or more severe trauma depending on the rigidity of the table and the position of the patient’s body. More critically, if the patient is connected to sensitive medical devices, tubes, or catheters, sudden rotational shifts can disconnect lines, cause internal injury, or disrupt the sterile field required for surgery. In worst-case scenarios, such instability can compromise the surgical outcome entirely, forcing an interruption in care or, in extreme cases, requiring emergency intervention to stabilize the patient.
Beyond the immediate physical harm, ignoring this recall introduces profound liability and operational risks for healthcare facilities. Using a known defective device violates standard of care protocols. If an injury occurs due to the failure of these specific components, the facility could face severe legal repercussions, including malpractice claims and regulatory penalties from agencies like the FDA. Furthermore, the breakdown of critical infrastructure during a procedure creates chaos in the operating room, diverting attention from the patient’s well-being to troubleshooting equipment failures. The peace of mind that comes from knowing your tools are reliable is fundamental to safe medical practice; ignoring this recall erodes that foundation entirely.
- Physical Trauma: Uncontrolled rotation can cause tissue damage, nerve compression, or bone injury due to unexpected shifts in patient positioning.
- Surgical Compromise: Loss of stability can disrupt precise surgical work, potentially leading to incorrect incisions or implant placement.
- Device Disconnection: Sudden movement may disconnect vital life-support lines or monitoring equipment, endangering the patient’s physiological stability.
- Legal and Regulatory Exposure: Continued use of a recalled Class II device exposes providers to significant liability if injuries occur.
Staying safe: broader tips
When dealing with complex medical equipment or specialized operating room hardware, safety often hinges on the details that aren’t immediately visible. While this specific recall highlights a mechanical failure in rotational locks and linear actuators, the underlying principle applies to many high-stakes devices: regular, structured maintenance is your best defense against unexpected failures. Manufacturers design these systems with intricate moving parts that endure significant stress. Over time, even minor wear on gears, sensors, or locking mechanisms can compromise safety features that are supposed to hold a patient securely in place. This is why adhering strictly to the manufacturer’s recommended service schedule is not just a bureaucratic requirement—it is a critical safety protocol. Routine inspections by qualified biomedical technicians can identify subtle signs of fatigue or misalignment long before they result in a malfunction during a procedure.
Beyond scheduled maintenance, staying informed about product safety is an ongoing responsibility for both healthcare facilities and patients. The U.S. Food and Drug Administration (FDA) maintains a robust database of recall notices, but these updates do not always reach every stakeholder instantly. It is wise to subscribe to official alert services from the FDA and the manufacturer directly. By registering your devices with IMRIS Imaging or other vendors, you ensure that you receive immediate notifications about safety communications, software updates, or field corrections. This proactive approach allows facilities to act quickly rather than reactively, minimizing risk to patients and ensuring compliance with regulatory standards.
Additionally, always verify the status of any medical device before use if there is any doubt about its service history. Check the Unique Device Identification (UDI) label on the equipment against current recall lists. In many cases, a simple online lookup can confirm whether a specific serial number or part number is subject to an active safety notice. For consumers and medical professionals alike, cultivating a culture of vigilance means never assuming that a device’s age guarantees its reliability. Mechanical components degrade, software updates may introduce new variables, and manufacturing batches can vary. By combining rigorous maintenance routines with active monitoring of official safety alerts, you create a multi-layered defense that protects everyone involved in the care process.
- Check your records: Periodically review your facility’s device logs against FDA recall databases to ensure no outdated equipment is in use.
- Register your devices: Sign up for direct alerts from manufacturers to receive real-time updates on safety notices and service bulletins.
- Verify UDI codes: Use the Unique Device Identification number on the label to cross-reference with current government safety lists.