Mobile X-ray systems recalled over bolts that may loosen or fracture
NeuroLogica is recalling 236 GM85 digital mobile X-ray systems because the four M5 bolts securing the tube head unit to the arm may loosen or fracture from metal fatigue.
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: Scored 3 under the risk-of-harm criterion: bolts that can fracture on a mounted tube head create a fall hazard, and no injuries are reported.
Plain-English summary
The GM85 Digital Mobile X-ray Imaging System, model GM85, from NeuroLogica, is being recalled.
The four M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
The recall covers 236 units carrying UDI-DI 08806088582412, distributed nationwide in the United States and internationally including Australia, Belgium, Canada, Chile, China Mainland and the Czech Republic. The FDA has classified the action as Class II.
The tube head is the heavy component at the end of the arm, so bolt failure creates a risk of it moving or falling. The enforcement record reports no injuries. Sites operating an affected system should follow the firm's instructions.
The recalled product
- Product
- GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
- Manufacturer
- NeuroLogica Corporation
- Category
- Medical Device — X-ray system
- Hazard
- metal-fatigue
- bolt-failure
- component-fall
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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