Reported Apr 26, 2023 · Ongoing
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
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 GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
- Lot codes and dates
- UDI-DI08806088582412
- GM85 systems S/N
935 of 935 codes
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
- UDI-DI08806088582412)
- Amount recalled
- 935 units
Where it was sold
- Nationwide
Why it was recalled
Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
This product could cause temporary or reversible health problems — stop using it.
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