NeuroLogica GM60A Mobile X-Ray System Anti-Fall Arm Safety Failure Risk
NeuroLogica has recalled its GM60A Digital Diagnostic Mobile X-Ray System due to potential failure of the anti-fall safety system in the device arm. The recall affects 31 units distributed nationwide.
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 designation with potential equipment failure risk in a safety system. No injuries, illnesses, or deaths reported. Per the rubric, risk-of-harm products without reported harm receive a score of 3 (High).
Plain-English summary
NeuroLogica Corporation has recalled the GM60A Digital Diagnostic Mobile X-Ray System due to a potential failure in the anti-fall safety system of the device arm.
A total of 31 units have been distributed nationwide across Arkansas, Connecticut, Georgia, Indiana, Kansas, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, Ohio, Pennsylvania, Virginia, West Virginia, and Washington DC.
The affected units are identified by NeuroLogica serial numbers ranging from G69812 to G73542, and corresponding Samsung serial numbers. No injuries or illnesses related to this issue have been reported.
The recalled product
- Product
- GM60A. Digital Diagnostic Mobile X-Ray System.
- Manufacturer
- NeuroLogica Corporation
- Affected units
- 31
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: 08806088511153/ 08806088088266
- Serial No. G69812
- G69821
- G69824
- G69986
- G69987
- G71422
- G71425
- G71431
- G71434
- G71795
- G71798
- G71802
- G72052
- G72053
- G72264
- G72279
- G72296
- G72301
- G72310
Distribution
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