GE OEC Elite and OEC 3D Mobile C-Arms Exceeding X-ray Field Limits
GE Medical Systems is recalling OEC Elite and OEC 3D Mobile C-arm systems with potential X-ray field size issues. Some units may exceed the 4% Source-to-Image Distance limit or lack documented acceptance limits in their service manuals.
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 FDA Class II recall involves a radiation safety specification issue with mobile C-arm imaging systems. Although no illnesses or injuries have been reported, X-ray field size exceeding documented limits represents a risk-of-harm scenario with potential for unintended radiation exposure.
Plain-English summary
GE Medical Systems is recalling OEC Elite and OEC 3D Mobile C-arm systems due to potential X-ray field size issues. Two populations are affected: systems that may exceed the 4% Source-to-Image Distance (SID) limit and do not have the acceptance limit documented in their System Service Manual, and systems that are within acceptable SID limits but lack the documented acceptance limit in their manual.
X-ray field size exceeding the 4% SID specification may result in unintended radiation exposure beyond the intended field of view. When acceptance limits are not documented in the service manual, healthcare facilities cannot properly verify that systems are operating within specifications during routine quality assurance and maintenance.
A total of 3,472 OEC Elite Mobile C-arm Systems and OEC 3D Mobile C-arm Systems are affected, including 2,919 units in the United States and 553 units outside the US. Detailed lists of affected serial numbers are available from GE Medical Systems. Healthcare facilities should immediately contact GE Medical Systems to determine if their systems are affected and for instructions regarding verification, service, or replacement.
The recalled product
- Product
- OEC 3D
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- x-ray-field-size
- radiation-exposure
Distribution
Distribution scope not specified by the agency.
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