Reported Jun 19, 2019 · Terminated
Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for…
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?
- Precision 500D 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.
- Lot codes and dates
204787RF1205814RF1209826500D229P500RF2410448RF417682BRF506857P500519663PR500519685PR500561791RM2603668C5618635RF636625SJR1718630PRECISION770793KP500D2810326P500850494WF4903731PRP500985230DCRF4and AM16KFZ328
- Amount recalled
- 825 (38 US and 787 OUS) in total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
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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