Reported Feb 12, 2014 · Terminated
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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 examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
- Lot codes and dates
- System ID Model, Catalogue or Code #FHFRF
658 of 658 codes
828213AIRF22385123-2309454FJRM12385123-2217935WF12385123-2434924UVAP12385123-2717627RF22385123-2608287PRE5002385123-2304473RF12385123-2717627RF12385123-2801807RM32385123-2904858RM12385123-2325658RF12385123-2828322F62385123-2623327RF12385123-2864573MBR32385123-2913696CRF12385123-2817255NHRM12385123-2217442VXF3A2385123-2509332PRF2385123-2405752P5002385123-2520498RF12385123-2718518RF22385123-2601426PRF12385123-2256MIRF12385123-2231876P500D12385123-2765448DF12385123-2404325EFL12385123-2231935DF22385123-2407321PRF52385123-2903416PD12385123-2970544RM22385123-2
973 of 973 codes
2385123-2361572RF12385123-2804541JR42385123-2770991RF22385123-2410337RF12385123-2989839RF12385123-2603444500D2385123-2412648P500D2385123-2775753P5002385123-2717544HCRF62385123-2904202WSRM32385123-2904202RF52385123-2229259P5002385123-2904321RF12385123-2508457RF32385123-2FHORF12385123-2406496P5002385123-2662459P5002385123-2334953MRF12385123-2919774RM42385123-241096822385123-2816501RF22385123-2802334500D2385123-2770991RF12385123-2816501RF32385123-2580323P5002385123-2757467RM12385123-2815968P500F2385123-2561791RM32385123-2208933500D2385123-2717544HCRF7
- System ID Model, Catalogue or Code #
- Amount recalled
- 816 (722 US, 94 OUS).
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems 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. This will not lead to an immediate fall of the suspended monitor since it will
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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