Samsung GM85 Mobile X-ray System Welding Frame Defect Arm Fall Risk
NeuroLogica is recalling 261 Samsung GM85 mobile x-ray systems due to a welding defect in the moving arm frame that could cause the arm to fall, risking bodily injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall involving a structural defect that presents risk-of-harm through potential arm failure and fall. No injuries or deaths have been reported in the source text, so the score does not exceed 3 per the rubric.
Plain-English summary
NeuroLogica Corporation is recalling approximately 261 Samsung Digital Diagnostic Mobile X-ray System, Model GM85 devices. These devices have been distributed nationwide across the United States.
The devices contain a welding defect in the moving arm frame. The defect presents a potential risk of bodily harm due to the possibility of the arm falling, which could cause serious injury to patients, caregivers, medical staff, or others in proximity to the equipment.
Affected devices can be identified by their serial numbers, which have been documented by the FDA.
The recalled product
- Product
- Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
- Manufacturer
- NeuroLogica Corporation
- Affected units
- 261
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)
- UDI-DI: 08806088582412
- serial numbers: 5143M3HK400010M
- 5143M3IJ800012D
- 5143M3IK400005T
- 5149M3IK400001H
- 5149M3IK400002K
- 5143M3IK400003Z
- 5143M3GK500001H
- 513YM3IK100001A
- 5143M3HJ500001Y
- 5143M3IJ600014H
- 5143M3HK400002V
- 5143M3JK400005Y
- 5143M3HJ900001L
- 5143M3IJ400007P
- 5143M3HK400007T
- 5143M3HK400003P
- 513YM3IJA00001X
- 5143M3JJ400007E
- 5143M3IJ400006V
Distribution
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