GE HealthCare OEC C-arm Systems recalled for missing radiation shielding
GE HealthCare is recalling certain OEC 9800 and OEC 9900 Elite C-arm Systems due to missing lead tape in collimator covers, which increases radiation exposure to patients and operators.
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 a medical device with a radiation hazard. No hospitalizations or injuries have been reported. Per the rubric, Class II recalls involving potential harm where injury has not yet been reported score as High (3).
Plain-English summary
GE HealthCare has identified a non-conformance in certain OEC 9800 and OEC 9900 Elite C-arm Systems. The systems are missing a full layer of lead tape in the collimator covers, which results in increased radiation exposure to both patients and operators.
The missing lead tape cannot be detected by users of the equipment. These systems have been distributed nationwide throughout the United States.
The recalled product
- Product
- GE HealthCare OEC 9900 Elite C-arm Systems.
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — C-arm Systems
- Hazard
- radiation-exposure
- missing-shielding
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 00840682114349
Distribution
Distributed nationwide across the United States.
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