High FDA (Devices)·Z-1989-2013·Announced 2013-08-28

GE Healthcare Precision 500D X-Ray Systems Recalled for Monitor Suspension Defect

GE Healthcare is recalling Precision 500D systems because a locking nut on the overhead video monitor suspension may loosen, posing a risk of impact.

What this means for you

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 is classified as FDA Class II. The hazard involves a potential impact from a loosening component, 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

GE Healthcare, LLC is recalling 445 Precision 500D systems, which are designed to perform radiographic and fluoroscopic x-ray examinations. The recall involves a potential safety issue with the overhead Video Monitor Suspension. Specifically, there is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke, which could result in impact. The source notes that this will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing.

The affected units were distributed worldwide, including nationwide in the United States and in Canada, France, Germany, Great Britain, Italy, Panama, and Saudi Arabia. The recall number is Z-1989-2013. The source text does not specify the corrective action consumers or facilities should take, nor does it report any injuries or illnesses associated with this defect.

The recalled product

Product: GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — X-Ray Equipment
Hazard: impact
mechanical-failure

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Same manufacturer · GE Healthcare, LLC

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Same hazard · impact