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.

Class I - Dangerous

🏥 Medical Devices Recalled: November 21, 2024 GE OEC Medical Systems Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Product Name: OEC 9900 GTIN code: 00840682114301 Lot/Serial Numbers / UDI codes: E2-0345 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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: GE OEC Medical Systems, Inc
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Product Name: OEC 9900 GTIN code: 00840682114301 Lot/Serial Numbers / UDI codes: E2-0345 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