FDA Medical devices recall ·
OEC Elite recall
- Recall number
- Z-0704-2025
- 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
- 100 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical 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 Elite GTIN code: 00001234567895 Lot/Serial Numbers / UDI codes: FAXXXE00254 (01)00840682121729(11)190400(21)FAXXXE00254 FBHXTX00837 (01)00840682121729(11)230300(21)FBHXTX00837 FBHXTX00912 (01)00840682121729(11)230500(21)FBHXTX00912 FBHXTX01278 (01)00840682121729(11)240800(21)FBHXTX01278 FBXXXE00731 (01)00840682121729(11)190500(21)FBXXXE00731 FBMHTX00470 (01)00840682121729(11)240900(21)FBMHTX00470 F2XXTX00801 (01)00840682121729(11)240800(21)F2XXTX00801 FBHXXX00171 (01)00840682121729(11)180600(21)FBHXXX00171 FBXXXE00715 (01)00840682121729(11)190500(21)FBXXXE00715 FBMHTX00444 (01)00840682121729(11)240600(21)FBMHTX00444 FBXXTE02974 (01)00840682121729(11)240800(21)FBXXTE02974 FBMHTX00466 (01)00840682121729(11)240900(21)FBMHTX00466 FAXXTE00672 (01)00840682121729(11)221200(21)FAXXTE00672 F9XXTX00276 (01)00840682121729(11)230900(21)F9XXTX00276 FAXXTE01160 (01)00840682121729(11)240800(21)FAXXTE01160 FBMHTX00454 (01)00840682121729(11)240800(21)FBMHTX00454 FBMHTX00455 (01)00840682121729(11)240800(21)FBMHTX00455 FBMHTX00465 (01)00840682121729(11)240900(21)FBMHTX00465 FBXXTE02975 (01)00840682121729(11)240800(21)FBXXTE02975 FBXXTE02976 (01)00840682121729(11)240800(21)FBXXTE02976 FBXXXE00312 (01)00840682121729(11)180900(21)FBXXXE00312 FAXXTE00664 (01)00840682121729(11)221100(21)FAXXTE00664 FBMHTX00450 (01)00840682121729(11)240700(21)FBMHTX00450 FAXXTE01154 (01)00840682121729(11)240700(21)FAXXTE01154 FBXXTE02994 (01)00840682121729(11)240800(21)FBXXTE02994 FAXXTE00544 (01)00
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-0704-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.