Reported Nov 19, 2025 · Ongoing
GM85 Digital Mobile X-ray imaging System; Model Number: 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?
- GM85 Digital Mobile X-ray imaging System
- Model NumberGM85
- Lot codes and dates
- Model NumberGM85
- UDI-DI08806088582412
- Serial Numbers
236 of 236 codes
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
- Amount recalled
- 236 units
Where it was sold
- Nationwide
Why it was recalled
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
This product could cause temporary or reversible health problems — stop using it.
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