Reported Sep 6, 2017 · Terminated
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human…
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 GU60A system- Digital X-ray Imaging Systems are 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
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
- Serial Numbers
- Amount recalled
- 87 units
Where it was sold
- Nationwide
Why it was recalled
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
This product could cause temporary or reversible health problems — stop using it.
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