GE OEC Medical Systems, Inc: OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagn

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: 25 systems Lot/code info: Product Name: OEC 9800 GTIN code: 00840682114349 Lot/Serial Numbers / UDI codes: 82XXXX04237 (01)00840682114349(11)170600(21)82XXXX04237 8S-2249 Not Applicable-MFG date prior to UDI compliance requirement 89-1022 Not Applicable-MFG date prior to UDI compliance requirement 82-1772 Not Applicable-MFG date prior to UDI compliance requirement 82-0980 Not Applicable-MFG date prior to UDI compliance requirement 8S-1793 Not Applicable-MFG date prior to UDI compliance requirement 82-2349 Not Applicable-MFG date prior to UDI compliance requirement 82-3361 Not Applicable-MFG date prior to UDI compliance requirement 8S-1398 Not Applicable-MFG date prior to UDI compliance requirement 82-0908 Not Applicable-MFG date prior to UDI compliance requirement 82-0599 Not Applicable-MFG date prior to UDI compliance requirement 8S-0533 Not Applicable-MFG date prior to UDI compliance requirement 82-0189 Not Applicable-MFG date prior to UDI compliance requirement 8S-0186 Not Applicable-MFG date prior to UDI compliance requirement 89-2415 Not Applicable-MFG date prior to UDI compliance requirement 8S-3259 Not Applicable-MFG date prior to UDI compliance requirement 8S-3426 Not Applicable-MFG date prior to UDI compliance requirement 89-1530 Not Applicable-MFG date prior to UDI compliance requirement 82-2955 Not Applicable-MFG date prior to UDI compliance requirement 8S-0958-RC Not Applicable-MFG date prior to UDI compliance requirement 82-1154 Not Applicable-MFG date prior to UDI compliance requirement

UPC codes

00840682114349

Source

Official record: FDA (Device enforcement) ↗

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