OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system
FDA device recall Z-0703-2025 · posted 2024-12-18 · Open, Classified
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- 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.
- Action taken
- On 11/21/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that GE HealthCare has become aware that recently manufactured OEC Elite and OEC 3D mobile C-arms, as well as recently replaced X-ray tubes on certain OEC Elite, OEC 3D and OEC 9900/OEC 9800 mobile C-arms potentially have insufficient sealing that can result in an oil leak. This issue could result in loss of fluoroscopic imaging capability. Customers are instructed to: 1.Continue to use their OEC Elite, OEC 3D, OEC 9900 and/or OEC9800 mobile C-arm. 2.If oil is found leaking from the X-ray tube on their OEC Elite, OEC 3D, OEC9900 and/or OEC 9800 mobile C-arm, contact the local GE HealthCareService representative. 3.Ensure all potential users in their facility are made aware of this safety notification and the recommended actions. 4.Please complete and return the attached acknowledgement form torecall.15150@gehealthcare.com. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to plan and schedule for the inspection and correction if needed. for any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OXO
- Quantity affected
- 84 systems
- 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.:
- Date initiated
- 2024-11-21
- Date posted
- 2024-12-18
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC 3D (K233669) | Ge Oec Medical Systems, Inc. | 2024-03-28 |
| OEC 3D (K203346) | Ge Oec Medical Systems, Inc. | 2021-03-05 |