Reported Jun 5, 2019 · Terminated
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for…
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 Mobile Digital
- X-ray Imaging System Product UsageThe GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
- Lot codes and dates
- Serial Numbers
288 of 288 codes
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
- Serial Numbers
- Amount recalled
- 288 systems
Where it was sold
- Nationwide
Why it was recalled
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
This product could cause temporary or reversible health problems — stop using it.
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