OEC Elite and OEC 3D Mobile C-Arms X-ray Field Size Defect
GE Medical Systems is recalling certain OEC Elite and OEC 3D mobile C-arm imaging systems because some units may produce X-ray fields that exceed acceptable limits, posing a potential radiation safety risk.
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: This is an FDA Class II recall involving diagnostic imaging equipment with a potential radiation safety hazard (X-ray field size exceeding acceptable limits). Although no illnesses or injuries are reported in the source, the hazard is real and involves medical devices used in patient care, meeting the threshold for High severity per the rubric.
Plain-English summary
GE Medical Systems, LLC is recalling certain OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944). The recalled units potentially have an X-ray field size greater than the 4% Source to Image Distance (SID) limit, or lack documented acceptance limits for X-ray field size measurement in the System Service Manual.
Two populations of systems are affected. First, systems listed in Appendix A have an X-ray field size that potentially exceeds the 4% SID limit and do not contain the acceptance limit in the System Service Manual. Second, systems not listed in Appendix A may be within the allowed SID limit, but lack the stated acceptance limit for X-ray field size measurement in the System Service Manual.
A total of 3,472 devices are affected globally, with 2,919 units distributed in the United States and 553 units distributed outside the United States. Affected serial numbers are listed in Appendix A of the FDA notice.
Users should verify their system serial number against the list in Appendix A and contact GE Medical Systems for instructions. The company is taking corrective actions to address the X-ray field size measurement documentation and performance issues in affected systems.
The recalled product
- Product
- OEC 3D
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- radiation-safety
- x-ray-field-size
Distribution
Distribution scope not specified by the agency.
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