NeuroLogica Recalls Samsung GU60A Digital X-ray Systems for Radiation Exposure
NeuroLogica Corporation is recalling 87 Samsung GU60A digital X-ray systems because unintended areas are exposed to radiation during the Stitching function.
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: The recall involves a risk of unintended radiation exposure, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
NeuroLogica Corporation is recalling 87 units of the Samsung GU60A Digital X-ray Imaging System. The recall is due to a defect where unintended areas are exposed to radiation when the device's Stitching function is performed.
These systems are intended for use in generating radiographic images of human anatomy by qualified or trained doctors or technicians. The device is not intended for mammographic applications. The affected units were distributed nationwide.
Healthcare facilities should contact NeuroLogica Corporation for instructions on how to address the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
- Manufacturer
- NeuroLogica Corporation
- Hazard
- Affected units
- 87
Distribution
Distributed nationwide across the United States.
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