OEC Elite: 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.
Reported: June 18, 2025 Initiated: March 21, 2025 #Z-1819-2025
Product Description
OEC Elite: 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.
Reason for Recall
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
Details
- Recalling Firm
- GE Medical Systems, LLC
- Units Affected
- Total for both products: 3472 (2,919 US; 553 OUS)
- Distribution
- US and OUS
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
OEC Elite: 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.. Recalled by GE Medical Systems, LLC. Units affected: Total for both products: 3472 (2,919 US; 553 OUS).
Why was this product recalled? ▼
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1819-2025.
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