FDA Medical devices recall ·
OEC 9900 recall
- Recall number
- Z-0705-2025
- Date
- (initiated November 21, 2024)
- Company / brand
- GE OEC Medical Systems, Inc
384 N Wright Brothers Dr, Salt Lake City, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 78 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
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 com
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
States: Alaska Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Jersey New Mexico Nevada New York Ohio Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0705-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.