The Recall Desk
ModerateFDA (Devices)·Z-0010-2015·Announced 2014-10-08

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.

What this means for you

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

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically: