What was recalled
The U.S. Food and Drug Administration (FDA) has initiated a Class II recall involving specific operating room tables manufactured by IMRIS Imaging Inc. This action, announced on August 6, 2026, targets precise models of the ORT200 operating room table. It is important to understand that this recall does not affect every table produced by the company, but rather focuses on particular assemblies and configurations that have been identified as having potential safety issues. The primary products involved in this recall are the ORT200 Covered Table Assembly (Reconditioned), which carries the specific Part Number 113821-600, and the ORT200 50/60Hz Covered Table Assy V2, identified by Part Number 114148-000. These are not general consumer goods but specialized medical equipment designed for use in surgical environments, where precision and stability are critical for patient safety.
To ensure that healthcare facilities can accurately identify whether their equipment is part of this recall, the FDA record provides very specific details regarding serial numbers and Unique Device Identifiers (UDI). For the reconditioned Covered Table Assembly with Part Number 113821-600, the recall applies to units with serial numbers 10003754 and 10006997. These are distinct, individual units that must be checked against facility inventory logs. For the V2 Covered Table Assy with Part Number 114148-000, the affected units are identified by the UDI-DI code 00857534006349 and include serial numbers 10005189, 10005190, 10004463, and 10004997. If a facility is unsure whether their table falls under these specific identifiers, they should consult the official FDA recall database or contact IMRIS directly for verification.
The distribution of these recalled tables was extensive, reaching a global market. While the recall encompasses units distributed nationwide within the United States, it also includes devices sold in international markets. Specifically, affected tables were distributed to Canada, China, Japan, and Sweden. This widespread distribution pattern means that hospitals, surgical centers, and medical institutions in all these regions need to conduct immediate checks of their inventory. The recall is centered around IMRIS Imaging Inc., which is located in Minnesota, but the impact extends far beyond this single state due to the international nature of medical device distribution. Understanding exactly which part numbers and serial numbers are involved is the first step in ensuring that any potentially compromised equipment is removed from service and addressed appropriately.
The hazard, explained
When you are undergoing a medical procedure, the operating room table is more than just a surface to lie on; it is a critical piece of life-support infrastructure that must remain perfectly stable. In this recall involving IMRIS Imaging Inc’s ORT200 operating room tables, the core issue lies in the mechanical systems that allow surgeons and technicians to adjust the patient’s position with precision. Specifically, the hazard stems from two interconnected components: the linear actuator and the rotational lock mechanism. To understand why this is dangerous, it helps to look at how these parts normally work together. The linear actuator is essentially a motor-driven screw or rod that moves the table up, down, or in specific directions. Meanwhile, the rotational lock acts like a heavy-duty clamp, holding the table firmly in place once the desired position is reached.
The problem identified by the FDA is that these components may experience a mechanical failure that prevents the system from successfully transitioning between its locked and unlocked states. In plain terms, this means the "clamping" function of the rotational lock can fail to engage or disengage as intended. If the mechanism fails to unlock when a technician tries to adjust the table, it creates resistance and potential strain on the equipment. However, the far more serious risk occurs if the lock fails to engage properly after an adjustment is made. In this scenario, the table may appear to be secure, but it lacks the necessary mechanical grip to hold its position against gravity or external forces.
This failure creates a direct pathway to patient injury through unintended rotational movement. Imagine a patient under anesthesia, completely unable to move or protect themselves, positioned for a delicate procedure. If the rotational lock mechanism fails while the table is in use, the heavy upper assembly of the table can suddenly shift, twist, or rotate without warning. This is not a minor wobble; it is a loss of structural integrity in the support system. Such unintended movement can cause the patient to slide, tilt abruptly, or be subjected to unexpected forces that could lead to falls, fractures, or internal injuries, especially if surgical instruments are already in place. The risk is compounded by the fact that these failures may not be obvious until they happen, leaving no time for correction during a critical moment in surgery.
While this specific recall details mechanical failure in the IMRIS ORT200 models, it highlights a broader principle in medical device safety: redundancy and reliability are vital. When a single point of failure in a locking mechanism can compromise patient stability, the entire procedure is at risk. This is why the FDA classifies such issues as Class II recalls, indicating a moderate to serious potential for injury if not addressed. Understanding this mechanism helps healthcare facilities prioritize immediate inspections, ensuring that the "locked" state truly means locked, and that no amount of pressure or movement will compromise the patient’s safety on the table.
Who is most at risk
To understand who is truly at risk in this recall, we first need to look at the setting. The IMRIS ORT200 is not a consumer product found in homes or retail stores; it is a specialized piece of medical equipment designed for use in operating rooms. Therefore, the primary group affected by this mechanical failure consists of patients who are undergoing surgical procedures on these specific tables. Unlike a recalled toy or a faulty car part that might impact owners during daily life, the risk here is confined to a very specific moment: when a patient is positioned on the table and a medical procedure is actively taking place.
The people most vulnerable to injury in this scenario are the patients themselves. The hazard involves the linear actuator and rotational lock mechanism failing, which prevents the table from transitioning between locked and unlocked states. In a surgical context, stability is everything. When a patient is under anesthesia or sedation, they cannot control their body position or protect themselves from sudden movements. If the locking mechanism fails and unintended rotational movement occurs, the patient’s body may twist or shift unexpectedly. This is particularly dangerous for elderly patients, who often have more fragile bones and tissues, or for patients undergoing orthopedic surgery where even minor shifts can compromise the precision of the operation or cause soft tissue damage.
While the recall distribution pattern includes the United States, Canada, China, Japan, and Sweden, it is important to note that we do not have specific data in the FDA record detailing which hospitals currently hold these units. This means that any patient scheduled for surgery at a facility that has purchased or leased an IMRIS ORT200 operating room table could potentially be affected. The risk is not limited by age, gender, or pre-existing conditions in a traditional sense; rather, it is purely situational. If you are the patient on the table when the mechanical failure happens, you are at direct risk of physical injury due to the unexpected movement.
It is also worth considering the medical staff who operate these tables. While they are not "at risk" of injury from the table moving in the same way a passive patient is, they face significant professional and clinical risks. A sudden mechanical failure during a delicate procedure can disrupt surgery, potentially leading to complications for the patient that might not have otherwise occurred. This puts surgeons, nurses, and anesthesiologists in a difficult position where they must react to equipment failure while trying to maintain patient safety.
In summary, the most at-risk individuals are patients currently or soon to be undergoing surgery on the affected ORT200 tables, particularly those who are immobilized by anesthesia. Because the remedy has not been stated in the official recall notice, it is crucial for healthcare facilities to verify their inventory immediately. If you or a loved one has upcoming surgery, do not panic, but do ask your surgical center if they use IMRIS ORT200 tables and whether they have inspected them for this specific defect.
How to tell if you have the recalled item
Identifying whether your medical facility is in possession of a recalled device requires careful attention to specific manufacturer details and unique identification numbers. Because this recall involves specialized operating room equipment, it is not something you will find on general retail shelves or through standard consumer channels. The affected products are the ORT200 operating room table manufactured by IMRIS. If your facility uses medical imaging or surgical tables, this is the specific brand and model line you need to verify.
The most reliable way to confirm if you have a recalled unit is to check the part numbers and serial numbers printed on the equipment’s nameplate or documentation. The recall specifically targets two distinct configurations of the ORT200 table, so you must look for one of the following exact part number combinations:
- ORT200 Covered Table Assembly, Reconditioned: This unit carries Part Number 113821-600. If your table has this part number, you must also verify the serial number. Only units with Serial Numbers 10003754 and 10006997 are included in this recall.
- ORT200 50/60Hz Covered Table Assy V2: This version is identified by Part Number 114148-000. For this model, you need to check both the Unique Device Identifier (UDI-DI) and the serial number. The UDI-DI for these units is 00857534006349. The recalled serial numbers for this part are 10005189, 10005190, 10004463, and 10004997.
If you are unsure where to find these numbers, they are typically located on a metal or adhesive tag attached to the base or side frame of the operating table. In many cases, this information is also recorded in your facility’s medical equipment inventory logs, purchase orders, or maintenance records. Because the distribution pattern for these devices is worldwide, including the United States, Canada, China, Japan, and Sweden, the location where you purchased the table may not help you determine if it is recalled; only the specific part and serial numbers matter.
It is important to note that the recall does not specify color or size as identifying factors. Therefore, visual inspection alone is not sufficient to rule out a recall. Even if your table looks identical to a non-recalled model, you must rely on the printed alphanumeric codes. If you cannot locate the nameplate, consult your biomedical engineering department or refer to the original installation documents provided by IMRIS at the time of purchase.
If you find that your equipment matches any of the part and serial numbers listed above, do not attempt to use it for patient procedures until further instructions are received. The FDA has classified this as a Class II recall, indicating that misuse or failure of the device could lead to serious injury, particularly due to the risk of unintended rotational movement during surgery. Accurate identification is the critical first step in ensuring patient safety and complying with federal safety regulations.
What to do — step by step
If you are part of a medical facility that uses the IMRIS ORT200 operating room table, or if you are a healthcare administrator responsible for patient safety protocols, it is critical to understand your immediate next steps regarding this FDA Class II recall. The primary concern here involves the linear actuator and rotational lock mechanism components, which may fail mechanically. This failure can prevent the system from properly transitioning between locked and unlocked states, potentially leading to unintended rotational movement of the table during a surgical procedure. Because this hazard poses a direct risk of injury to patients, acting promptly is not just a regulatory formality—it is a vital safety measure.
Step 1: Immediately Suspend Use of Affected Units
The first and most important action you must take is to stop using any recalled ORT200 operating room tables immediately. Do not wait for further instructions from the manufacturer or the FDA before halting operations involving these specific devices. The risk of mechanical failure during a procedure is too significant to ignore. If these tables are currently in use, they should be removed from active surgical schedules right away. This step is crucial because the recall highlights a potential for unintended movement that could compromise patient stability and safety while under anesthesia or during delicate surgical interventions. By taking the device offline, you eliminate the immediate risk of injury associated with the defective rotational lock mechanism.
Step 2: Identify Your Specific Equipment
You need to verify whether your facility possesses any of the specific models and serial numbers listed in this recall. The affected products include the ORT200 operating room table, specifically the ORT200 Covered Table Assembly (Reconditioned) with Part Number 113821-600, and the ORT200 50/60Hz Covered Table Assy V2 with Part Number 114148-000. Please check your equipment logs carefully. For Part Number 113821-600, the affected serial numbers are 10003754 and 10006997. For Part Number 114148-000, the affected serial numbers are 10005189, 10005190, 10004463, and 10004997. Additionally, for the V2 assembly, you may reference the Unique Device Identifier (UDI-DI): 00857534006349. If your equipment matches these identifiers, it is definitively part of this recall.
Step 3: Contact IMRIS Imaging Inc for Remediation
Once you have identified that you possess a recalled unit, you must contact the manufacturer to arrange for the next phase of the remedy. However, it is important to note that the official recall announcement from the FDA does not currently state the specific remedy details, such as whether you will receive a repair kit, a replacement part, or a full unit exchange. Because this information is missing from the public record at this time, your best course of action is to reach out to IMRIS Imaging Inc directly. They are the only entity with the authority and technical knowledge to provide you with the specific instructions for returning, repairing, or replacing these devices. Do not attempt to repair the linear actuator or rotational lock mechanism yourself, as improper handling could exacerbate the safety risk.
Step 4: Document Your Actions
Keep detailed records of your communication with IMRIS Imaging Inc and your internal decision to remove the device from service. This documentation is essential for regulatory compliance and for ensuring that your facility has met its duty of care to patients. Since this recall involves worldwide distribution, including units in the United States, Canada, China, Japan, and Sweden, ensure that your records clearly reflect the location and status of each affected unit. If you are in a region where local distributors handle IMRIS products, contact them as well, but always confirm their instructions with the manufacturer to ensure they align with the FDA’s Class II recall requirements.
Your refund, repair, or replacement options
When you are dealing with a medical device recall, the most immediate question is often, "What happens next?" In this specific instance involving IMRIS Imaging Inc., the situation regarding your remedy requires careful attention because the official FDA recall facts do not currently state a specific corrective action. This means that standard procedures for refunds, repairs, or replacements have not been explicitly detailed in the public record as of the recall date on August 6, 2026. While it might be unsettling to encounter this gap, it is important to understand that the absence of a stated remedy does not mean you are left without recourse; rather, it highlights the critical importance of direct communication with the manufacturer.
Typically, in Class II device recalls, the remedy involves one of three paths: a repair where the manufacturer sends a technician or parts to fix the specific mechanical failure, a replacement unit if the defect is systemic and cannot be easily repaired, or a refund if the device is returned. In this case, because the hazard involves a mechanical failure in the linear actuator and rotational lock mechanism of the ORT200 operating room table, a repair would be the most logical technical solution to restore safety. However, since these details are not provided in the recall notice, you must rely on IMRIS Imaging Inc. to outline their specific plan for affected parties.
To find out exactly what options are available to you—whether that is a free repair, a replacement table assembly, or other compensation—you need to contact the company directly. The official records indicate that distribution occurred worldwide, including in the United States, Canada, China, Japan, and Sweden, so IMRIS has established channels for global inquiries. You should look for the contact information provided by IMRIS Imaging Inc., which is typically found on their official website or in direct correspondence from their recall team. Do not assume a standard policy applies; each recall can have unique terms depending on the age of the device, the warranty status, and the specific serial number involved.
If you are a healthcare facility administrator or a patient who has recently used one of these tables, take proactive steps immediately. Gather your documentation, including the part numbers (113821-600 or 114148-000) and serial numbers (such as 10003754, 10006997, 10005189, 10005190, 10004463, or 10004997) found on your device. When you reach out to IMRIS, have these details ready. This will help them identify your specific unit and determine what remedy they are offering. It is possible that the remedy may involve sending a technician to inspect the rotational lock mechanism or providing a new covered table assembly. Until you speak with their customer support or regulatory affairs team, do not attempt to modify the device yourself, as this could void any potential warranty or replacement offer.
In summary, while the general expectation in such recalls is that the manufacturer will rectify the safety issue at no cost to the user, the specific terms for this IMRIS recall are not yet public. Your next step is to initiate contact with IMRIS Imaging Inc. to inquire about their remedy plan. They are responsible for informing you of whether you will receive a repair, a replacement part, or another form of resolution. Stay patient but persistent in your communications, as resolving this mechanical hazard is essential for ensuring the safety of future medical procedures.
What can happen if you ignore it
When a medical device like the IMRIS ORT200 operating room table fails in such a critical way, ignoring the recall is not merely an administrative oversight—it is a direct threat to patient safety during some of the most vulnerable moments of their care. The core issue here is mechanical: the linear actuator and rotational lock mechanism may fail, leaving the table stuck in one position or, worse, allowing unintended movement when it should be rigidly fixed. In a surgical setting, stability is not a luxury; it is the foundation upon which precise medical interventions are built. If you continue to use this equipment after the recall date of August 6, 2026, you are risking a scenario where the table shifts unexpectedly while a surgeon is making delicate incisions or placing implants.
The consequences of ignoring this warning are severe and immediate. The primary danger is unintended rotational movement during a procedure. Imagine a patient under anesthesia, positioned carefully for hours, only to have their body rotate slightly due to a mechanical failure in the table’s locking system. This shift can disrupt the surgical field, forcing doctors to stop mid-procedure to reposition the patient. This isn’t just an inconvenience; it increases the time the patient spends under anesthesia, raises the risk of infection from broken sterile fields, and can lead to serious physical injuries such as nerve damage, pressure sores, or musculoskeletal strain from improper alignment.
Furthermore, if the mechanism fails completely and prevents the system from transitioning between locked and unlocked states, the table could become immobile when adjustments are needed, or it could collapse or tilt unexpectedly. This unpredictability creates a chaotic environment in the operating room, where staff must divert their attention from the patient to manage the equipment failure. In emergency situations, every second counts, and a malfunctioning table can delay critical care. While the recall notice does not specify that injuries have already occurred, the potential for harm is inherent in the design flaw. A device meant to hold a human body steady becomes a hazard when it cannot maintain its position. Ignoring this recall means accepting that risk without any mitigation, leaving patients exposed to preventable mechanical failures at the very moment they need the most stability.
- Sudden, uncontrolled rotation of the patient during surgery
- Inability to adjust table height or angle when needed
- Extended anesthesia times due to procedural interruptions
- Increased risk of surgical errors due to unstable positioning
Staying safe: broader tips
When we talk about medical equipment like operating room tables, it is easy to feel that safety is entirely the responsibility of the hospital staff or the manufacturer. While they certainly hold significant accountability for design and manufacturing quality, there are practical, general steps you can take as a patient or consumer to stay informed and protected. The most powerful tool in your hands is awareness. Medical devices are complex machines with moving parts, electronics, and structural components that undergo wear and tear over time. Understanding that these devices require ongoing vigilance helps shift the mindset from passive usage to active safety partnership.
First and foremost, make it a habit to regularly check for recalls on the products you use or encounter in clinical settings. You do not need to wait for news alerts to appear on your social media feed. Instead, proactively visit the official websites of the regulatory bodies that oversee these products, such as the U.S. Food and Drug Administration (FDA) or the Consumer Product Safety Commission (CPSC), depending on the item type. These agencies maintain searchable databases where you can look up specific brands, model numbers, or even hazard types. Setting a reminder to review these lists once a quarter ensures that you are not caught off guard by sudden updates. If you are a healthcare administrator or facility manager, establish a routine protocol for cross-referencing your inventory against these official recall notices immediately upon publication.
For patients, especially those undergoing surgery or long-term treatments, do not hesitate to ask questions about the equipment being used. It is perfectly appropriate and encouraged to ask your care team if they are aware of any recent safety notices regarding the specific devices in use. This does not imply distrust; rather, it reflects a culture of safety where transparency is valued. In many cases, facilities have strict protocols for inspecting and maintaining their equipment, but knowing that you or your loved one is aware of these standards can provide peace of mind. If you notice any unusual sounds, resistance, or behavior from medical devices at home—such as mobility aids or monitoring equipment—stop using them immediately and contact the manufacturer or a qualified technician.
Additionally, maintain clear records of your medical device usage. Keep receipts, warranty information, and serial numbers in a safe, accessible digital folder. If a recall is issued, having this documentation ready will speed up any potential remedy process, whether it involves repair, replacement, or refund. Finally, remember that safety is a shared responsibility. By staying educated about the types of hazards associated with medical devices—such as mechanical failures, electrical issues, or material defects—you empower yourself to act quickly and effectively if something goes wrong. This proactive approach not only protects you but also helps manufacturers and regulators identify patterns and improve future designs.
- Bookmark official recall databases for regular checks.
- Maintain organized records of device serial numbers and purchase dates.
- Communicate openly with healthcare providers about equipment safety concerns.
- Report any unusual device behavior to the manufacturer immediately.