Visaris recalls Vision/Auto X-Ray systems (Version 2.2) due to possible tube arm suspension failure during height adjustment, risking patient injury. Affected models include VC16B-02002 and others with specific serial numbers.
A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube height adjustment there is a small probability of failure of both the primary and redundant holding mechanisms, causing uncontrollable descent of the tube arm and a potential risk of injury to the patient.
Visaris is recalling its Vision/Auto and ddRAura OTC APS diagnostic X-ray systems (Version 2.2) because adjusting the tube arm height might cause it to drop uncontrollably, potentially injuring patients. This risk is specific to systems used in medical settings with immobile patients.
During height adjustments, the tube arm suspension could fail, causing both primary and redundant holding mechanisms to malfunction. This might lead to the tube arm descending uncontrollably, which could injure the patient if they are in the path of movement.
Healthcare facilities using Visaris Vision/Auto or ddRAura OTC APS X-ray systems for immobile patients, such as trauma wards or emergency departments, are most at risk. Patients in these settings could be injured if the tube arm drops unexpectedly.
Check for the system model names: Vision/Auto, ddRAura OTC APS, and Version 2.2. Affected units have specific serial numbers like VC16B-02002 or VC15L-02002 with matching column serial numbers listed in the recall notice.
Look for the system serial numbers (e.g., VC16B-02002) and column serial numbers (e.g., BA-215-1800-862-1-30008) on the equipment to confirm if it is affected.
During tube height adjustments, there is a small probability of both primary and redundant holding mechanisms failing, causing the tube arm to drop uncontrollably and potentially injuring the patient.
Facilities using these systems for immobile patients, such as trauma wards and emergency departments, are most at risk due to the potential for uncontrolled tube arm movement.
Check for the system model names (Vision/Auto, ddRAura OTC APS) and Version 2.2. Affected units have specific serial numbers like VC16B-02002 with matching column serial numbers listed in the recall notice.
We’ve drafted a message you can send Visaris to request your refund or repair — edit it as you like.
Subject: Recall Z-1880-2018 — Visaris Visaris Hello, I own a Visaris that is covered by recall Z-1880-2018 from Visaris. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
