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.
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 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
Distribution
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