Agency classClass IIOur severity:High FDA (Devices)·Z-0804-2014·Announced 2014-01-29

GE Healthcare Recalls X-Ray Systems with Missing Monitor Suspension Screws

GE Healthcare is recalling 5,651 X-ray systems worldwide because four outer screws holding the overhead video monitor suspension may be missing. No monitor falls have been reported.

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 heavy equipment) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards without confirmed incidents.

Plain-English summary

GE Healthcare, LLC is recalling 5,651 units of Fluoroscopic and Radiographic X-Ray systems, including the Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII models. The recall involves the overhead Video Monitor Suspension component, where GE discovered that the four outer screws holding the suspension to the carriage were missing since the system's installation.

The affected systems are intended for universal diagnostic imaging of adult and pediatric subjects. The products were distributed worldwide, including the United States, Washington D.C., Guam, Puerto Rico, and numerous international locations. GE is not aware of any incidents where the overhead monitor suspension has fallen.

Healthcare facilities should contact GE Healthcare to verify if their systems are affected and to arrange for the necessary repairs or inspections to ensure the monitor suspension is securely attached.

The recalled product

Product: Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Diagnostic Imaging
Hazard: falling-object
structural-defect
Affected units: 5,651

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 (20)

serial numbers: 182
00000000159728
719723
00000000045GP5
00000000047GP1
00000000120GP6
00000000167GP7
00000000168GP5
00000000169GP3
00000000170GP1
00000000171GP9
00000000175GP0
00000000177GP6
00000000180GP0
00000000182GP6
00000000184GP2
00000000185GP9
00000000186GP7
00000000190GP9
00000000223GQ8

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · GE Healthcare, LLC

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