Reported Jul 8, 2015 · Terminated
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic…
GE Healthcare
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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
- Lot codes and dates
- Mfg Lot or Serial # Model, Catalogue or Code #
2,714 of 2,714 codes
00000959002WK7225862700000966338WK6225862700000966611WK6225862700000956387WK5225862700000968741WK9225862700000961510WK5225862700000972529WK2225862700000962527WK8225862700000963526WK9225862700000955594WK7225862700000956587WK0225862700000959354WK2225862700000964963WK3225862700000955822WK2225862700000969028WK0225862700000970010WK5225862700000977743WK4225862700000977741WK8225862700000961823WK2225862700000966949WK0225862700000974520WK9225862700000969300WK3225862700000980632WK4225862700000968416WK8225862700000954452WK9225862700000976569WK4225862700000966357WK6225862700000965746WK1225862700000973833WK7225862700000968411WK92258627
- Mfg Lot or Serial # Model, Catalogue or Code #
- Amount recalled
- 4,053 (3,804 US; 249 OUS)
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
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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