OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy
FDA device recall Z-1819-2025 · posted 2025-06-09 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
- Action taken
- All impacted customers with receive a customer letter notifying them of the potential issue. GE HealthCare will send a field service engineer to perform measurements of the Xray field on the identified systems (listed in Appendix A of the customer letter).
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OXO
- Quantity affected
- Total for both products: 3472 (2,919 US; 553 OUS)
- Distribution
- US and OUS
- Date initiated
- 2025-03-21
- Date posted
- 2025-06-09
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC Elite (K192819) | Ge Oec Medical Systems, Inc. | 2019-11-08 |
| OEC Elite (K172550) | Ge Oec Medical Systems, Inc. | 2017-11-16 |
| OEC Elite (K171565) | Ge Oec Medical Systems, Inc. | 2017-08-10 |
| OEC Elite (K170752) | Oec Medical Systems, Inc. | 2017-05-19 |