Reported Feb 21, 2024 · Ongoing
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
NeuroLogica Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NeuroLogica Corporation · 14 Electronics Ave · Danvers, MA · 01923-1011
Is this the product you have?
- Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
- Lot codes and dates
- UDI-DI08806088582412
- serial numbers
261 of 261 codes
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
- Amount recalled
- 261 devices
Where it was sold
Why it was recalled
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
This product could cause temporary or reversible health problems — stop using it.
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