Visaris recalls Vision/Auto X-Ray systems (Version 2.3) due to possible tube arm suspension failure during height adjustment, risking patient injury. Affected units include specific system and column serial numbers listed in the recall notice.
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 2.3) because adjusting the tube arm height might cause it to drop uncontrollably, potentially injuring patients. This risk occurs during normal use in medical settings where patients are immobile or require specialized positioning.
During tube height adjustment, the suspension system has a small probability of failing both primary and redundant holding mechanisms. This could cause the tube arm to descend uncontrollably, potentially causing injury to the patient.
Healthcare facilities using the Vision/Auto X-Ray systems (Version 2.3) with specific system and column serial numbers listed in the recall notice are most at risk. Patients in trauma wards or emergency departments using these systems could be affected.
Check for system serial numbers (e.g., VC16J-01002, VC16F-04002) and column serial numbers (e.g., BA-215-1800-862-1-3 0022) listed in the recall notice. The systems are intended for use in medical facilities with immobile patients.
Identify the system serial numbers (e.g., VC16J-01002, VC16F-04002) and column serial numbers (e.g., BA-215-1800-862-1-3 0022) from the recall notice.
Reach out to Visaris DOO for guidance on whether your specific unit is affected and next steps.
The recalled systems are Visaris Vision/Auto and ddRAura OTC APS diagnostic X-ray systems (Version 2.3).
Check for system serial numbers (e.g., VC16J-01002, VC16F-04002) and column serial numbers (e.g., BA-215-1800-862-1-3 0022) listed in the recall notice.
The recall notice does not specify a fix; affected units should be checked with the manufacturer for guidance.
We’ve drafted a message you can send Visaris to request your refund or repair — edit it as you like.
Subject: Recall Z-1881-2018 — Visaris Visaris Hello, I own a Visaris that is covered by recall Z-1881-2018 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.
