GE Healthcare Recalls X-ray Systems Due to Monitor Suspension Nut Issue
GE Healthcare is recalling Precision 500D, MPI, and RXI X-ray systems because a locking nut on the overhead monitor suspension may loosen.
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-harm product (falling monitor) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling the Precision 500D, Precision MPI, and Precision RXI X-ray imaging systems. The recall involves 816 units distributed worldwide, including 722 in the United States and 94 outside the US.
The recall is due to a potential safety issue with the overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. The source text notes that this will not lead to an immediate fall of the suspended monitor.
Affected units are intended for use by qualified doctors or technicians for diagnostic radiographic and fluoroscopic examinations. Users should contact GE Healthcare for further instructions regarding the repair or replacement of the affected suspension components.
The recalled product
- Product
- GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. 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…
- Manufacturer
- GE Healthcare, LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- System ID Model
Distribution
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