Reported Dec 25, 2024 · Ongoing
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is…
GE OEC Medical Systems, Inc.
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 OEC Medical Systems, Inc · 384 N Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
- OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
- Lot codes and dates
- Product NameOEC 9900
- GTIN code00840682114301
- Lot/Serial Numbers / UDI codesE2-0345 Not Applicable-MFG date prior to UDI compliance requirement E2-7031-MH Not Applicable-MFG date prior to UDI compliance requirement E2-1862 Not Applicable-MFG date prior to UDI compliance requirement ES-0942 Not Applicable-MFG date prior to UDI compliance requirement E9-1101 Not Applicable-MFG date prior to UDI compliance requirement E9-2173 Not Applicable-MFG date prior to UDI compliance requirement E9-2706 Not Applicable-MFG date prior to UDI compliance requirement E2-5146 Not Applicable-MFG date prior to UDI compliance requirement E2-1777 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05533 (01)00840682114301(11)160600(21)E2XXXX05533 ES-3271 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05700 (01)00840682114301(11)160900(21)E2XXXX05700 E2XXXX06210 (01)00840682114301(11)170900(21)E2XXXX06210 E2MHXX07986 (01)00840682114301(11)170500(21)E2MHXX07986 E9-2586 Not Applicable-MFG date prior to UDI compliance requirement ES-1901 Not Applicable-MFG date prior to UDI compliance requirement E9-2999 Not Applicable-MFG date prior to UDI compliance requirement ESXXXX04466 (01)00840682114301(11)190100(21)ESXXXX04466 ES-2359 Not Applicable-MFG date prior to UDI compliance requirement E9-1824 Not Applicable-MFG date prior to UDI compliance requirement E2-4112 Not Applicable-MFG date prior to UDI compliance requirement E2-0633 Not Applicable-MFG date prior to UDI compliance requirement E9-0156 Not Applicable-MFG date prior to UDI compliance requirement ES-3537 Not Applicable-MFG date prior to UDI compliance requirement ES-0348 Not Applicable-MFG date prior to UDI compliance requirement ES-1269 Not Applicable-MFG date prior to UDI compliance requirement E9-2634 Not Applicable-MFG date prior to UDI compliance requirement E9-0763 Not Applicable-MFG date prior to UDI compliance requirement E2MHXX07958 (01)00840682114301(11)160900(21)E2MHXX07958 E2-4224 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05753 (01)00840682114301(11)161000(21)E2XXXX05753 ES-0186 Not Applicable-MFG date prior to UDI compliance requirement ES-1648 Not Applicable-MFG date prior to UDI compliance requirement ESXXXX04227 (01)00840682114301(11)170800(21)ESXXXX04227 ES-2800 Not Applicable-MFG date prior to UDI compliance requirement E2-2074 Not Applicable-MFG date prior to UDI compliance requirement E9XXXX03158 (01)00840682114301(11)170100(21)E9XXXX03158 ES-1390 Not Applicable-MFG date prior to UDI compliance requirement ESXXXX03869 (01)00840682114301(11)160800(21)ESXXXX03869 E9XXXX03157 (01)00840682114301(11)170100(21)E9XXXX03157 E2XXXX06067 (01)00840682114301(11)170400(21)E2XXXX06067 ES-1476 Not Applicable-MFG date prior to UDI compliance requirement ES-0317 Not Applicable-MFG date prior to UDI compliance requirement ES-1011 Not Applicable-MFG date prior to UDI compliance requirement E2-3459 Not Applicable-MFG date prior to UDI compliance requirement ES-0144 Not Applicable-MFG date prior to UDI compliance requirement ES-0336 Not Applicable-MFG date prior to UDI compliance requirement E9-2976 Not Applicable-MFG date prior to UDI compliance requirement E2-7081-MH Not Applicable-MFG date prior to UDI compliance requirement E2-4029 Not Applicable-MFG date prior to UDI compliance requirement E2-4133 Not Applicable-MFG date prior to UDI compliance requirement E2-5039 Not Applicable-MFG date prior to UDI compliance requirement E2-7161-MH Not Applicable-MFG date prior to UDI compliance requirement E2-4550 Not Applicable-MFG date prior to UDI compliance requirement E9-1488 Not Applicable-MFG date prior to UDI compliance requirement E2-4026 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05597 (01)00840682114301(11)160600(21)E2XXXX05597 E2-4617 Not Applicable-MFG date prior to UDI compliance requirement ES-0515 Not Applicable-MFG date prior to UDI compliance requirement E2-2621 Not Applicable-MFG date prior to UDI compliance requirement E9-1434 Not Applicable-MFG date prior to UDI compliance requirement E2-2531 Not Applicable-MFG date prior to UDI compliance requirement E2-1272 Not Applicable-MFG date prior to UDI compliance requirement ES-1439 Not Applicable-MFG date prior to UDI compliance requirement E9-2364 Not Applicable-MFG date prior to UDI compliance requirement ES-2273 Not Applicable-MFG date prior to UDI compliance requirement ES-2603 Not Applicable-MFG date prior to UDI compliance requirement E2-0371 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05573 (01)00840682114301(11)160600(21)E2XXXX05573 E9-2096 Not Applicable-MFG date prior to UDI compliance requirement ES-0717 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05451 (01)00840682114301(11)160500(21)E2XXXX05451 E9XXXX03164 (01)00840682114301(11)170100(21)E9XXXX03164 E2-4265 Not Applicable-MFG date prior to UDI compliance requirement E9-2471 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX06639 (01)00840682114301(11)181000(21)E2XXXX06639 E9-2720 Not Applicable-MFG date prior to UDI compliance requirement E9-2710 Not Applicable-MFG date prior to UDI compliance requirement
- Amount recalled
- 78 systems
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
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
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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