GE OEC Medical Systems, Inc: 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

Hazard

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.

Details from the source

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. Distribution: U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United Kingdom Quantity: 78 systems Lot/code info: 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 com

UPC codes

00840682114301

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.