FDAApril 5, 2018device
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suite...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
visaris doovisaris
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCBombardier Recreational Products (BRP) Recalls Ski-Doo Snowmobiles Due to Risk of Serious Injury and Crash Hazard2024-02-29
- CPSCBombardier Recreational Products (BRP) Recalls Ski-Doo and Lynx Snowmobiles Due to Fire Hazard (Recall Alert)2023-08-31
- CPSCBombardier Recreational Products (BRP) Expands Recall of Snowmobiles Due to Fire Hazard (Recall Alert)2023-05-11
- CPSCBombardier Recreational Products (BRP) Recalls Snowmobiles Due to Fire Hazard (Recall Alert)2022-10-13
- CPSCBRP Recalls Snowmobiles Due to Fire Hazard (Recall Alert)2022-03-03
- CPSCBRP Recalls Snowmobiles Due to Crash Hazard (Recall Alert)2022-02-10
- FDAVisaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suite...2018-04-05
- FDAVisaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suite...2018-04-05
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