GE Healthcare Precision 500D X-ray Systems Recalled for Missing Screws
GE Healthcare is recalling Precision 500D X-ray systems because missing screws may cause the overhead video monitor to detach from the tray assembly.
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 hazard involves a potential mechanical failure (falling monitor) without reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
GE Healthcare, LLC is recalling 204 units of the Precision 500D, Classical R&F System X-ray imaging systems. The recall is due to a potential safety issue where screws used to mount the overhead Video Monitor to the tray assembly on a single monitor suspension may be missing.
The affected systems are intended for use as universal diagnostic imaging systems for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations. The recall covers units distributed nationwide in the United States and in Canada, Germany, and the United Kingdom.
Healthcare facilities should check their equipment against the specific serial numbers listed in the official recall notice to determine if their units are affected. If a unit is affected, the facility should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
- Manufacturer
- GE Healthcare, LLC
- Hazard
Distribution
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