Visaris recalls Vision/Auto X-Ray Systems Version 2.4 due to possible tube arm suspension failure during height adjustment, risking patient injury. Affected units include specific serial numbers for US and international markets.
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 2.4) because a tube arm suspension failure could cause the X-ray arm to drop uncontrollably during height adjustments, potentially injuring patients. This risk occurs during routine use in medical settings where the system is used for immobile patients.
During height adjustments of the X-ray tube arm, the suspension system might fail, causing both primary and backup holding mechanisms to malfunction. This could lead to the tube arm descending uncontrollably, potentially causing injury to the patient.
Healthcare facilities using the affected Vision/Auto X-ray systems for patient imaging, particularly trauma wards and emergency departments with immobile patients. Medical staff and patients at these sites are most at risk.
Check for the specific system serial numbers listed: US systems include VC17J-02002, VC17F-01002, VC17C-01002; international systems include VC17J-02002, VC17I-01002, VC17G-02002, VC16K-01002. The systems are intended for use in diagnostic radiography at secondary and tertiary medical care levels.
Identify the system serial numbers from the list provided in the recall notice to confirm if your unit is affected.
The recall is due to a possible failure of the tube arm suspension during height adjustments, which could cause the X-ray tube arm to drop uncontrollably and risk patient injury.
Affected models include US systems with serial numbers VC17J-02002, VC17F-01002, VC17C-01002 and international systems with serial numbers VC17J-02002, VC17I-01002, VC17G-02002, VC16K-01002.
No immediate stop is required, but affected units should be checked for the specific serial numbers listed and any necessary actions taken as per the recall instructions.
We’ve drafted a message you can send Visaris to request your refund or repair — edit it as you like.
Subject: Recall Z-1882-2018 — Visaris Visaris Hello, I own a Visaris that is covered by recall Z-1882-2018 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.
