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 diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Enforcement
- Recall Number
- Z-0706-2025
- Event ID
- 95846
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE OEC Medical Systems, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 25, 2024
- Initiation Date
- November 21, 2024
- Classification Date
- December 18, 2024
- Address
- 384 N Wright Brothers Dr, Salt Lake City, UT, 84116-2862, United States
Description
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 diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
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.
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 8S-3032 Not Applicable-MFG date prior to UDI compliance requirement 8S-3145 Not Applicable-MFG date prior to UDI compliance requirement 89-1916-RC Not Applicable-MFG date prior to UDI compliance requirement 82-4134 Not Applicable-MFG date prior to UDI compliance requirement
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
25 systems