NeuroLogica GC80 Digital X-ray Imaging System Recalled for Overexposure
NeuroLogica Corporation is recalling 45 units of the GC80 Digital X-ray Imaging System because images obtained during examinations may be overexposed.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a technical defect (overexposure) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
NeuroLogica Corporation is recalling 45 units of the GC80 Digital X-ray Imaging System. The recall was initiated because an image was obtained with overexposure during a Thorax examination using the AEC function.
The affected units were distributed nationwide in the United States. The specific issue involves the Automatic Exposure Control (AEC) function, which resulted in overexposed images during the reported examination.
Healthcare facilities and users of the GC80 Digital X-ray Imaging System should contact NeuroLogica Corporation for instructions on how to resolve the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- The GC80 Digital X-ray Imaging System
- Manufacturer
- NeuroLogica Corporation
- Hazard
- Affected units
- 45
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 (1)
- Accession Number 1310459
Distribution
Distributed nationwide across the United States.
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