[pending] GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Pending LLM rewrite. Source: FDA_DEVICE Z-0480-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
- Manufacturer
- NeuroLogica Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: GM85
- UDI-DI: 08806088582412
- Serial Numbers: 514GM3IK400001L
- 5143M3IK300001X
- 5143M3IJ100010M
- 5143M3IHC00014H
- 5143M3IK300008R
- 5143M3JJ400007E
- 5143M3HJ900002V
- 5143M3IK400004F
- 513YM3IK500003Z
- 5143M3HK600005V
- 5143M3JJ200010J
- 5143M3HK600008M
- 5143M3HK200004H
- 5143M3JK500003W
- 5143M3IJ200002F
- 5143M3IHC00007A
- 5143M3JJ300001K
- 5143M3IJ600014H
Distribution
Distributed nationwide across the United States.
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