Reported Jan 29, 2014 · Terminated
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D,…
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?
- Video Monitor Suspensions that may be on the following Fluoroscopic
- and Radiographic X-Ray systemsPrecision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI
- and Prestige SII Product UsageThe systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used 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
- serial numbers
2,178 of 2,178 codes
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
- serial numbers
- Amount recalled
- 5651
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of the overhead monitor suspension.
This product could cause temporary or reversible health problems — stop using it.
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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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