[pending] OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of
Pending LLM rewrite. Source: FDA_DEVICE Z-1819-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
The recalled product
- Product
- 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.
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Devices
Distribution
Distribution scope not specified by the agency.
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