C-arm imaging systems recalled over missing lead tape in collimator covers
GE HealthCare OEC 9800 and OEC 9900 Elite C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes increased radiation exposure to patients and operators with no injuries reported.
Plain-English summary
GE HealthCare OEC 9900 Elite C-arm Systems, GTIN 00840682114349, are being recalled, with distribution nationwide in the United States.
GE HealthCare became aware of a non-conformance to 21 CFR 1020.30(k) in certain OEC 9800 and OEC 9900 Elite C-arm systems. Impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The manufacturer states the missing lead tape is not detectable by the user. The FDA classified the action as Class II.
Imaging sites operating these systems should follow the manufacturer's instructions for inspection and correction. GE HealthCare is contacting affected customers directly.
The recalled product
- Product
- GE HealthCare OEC 9900 Elite C-arm Systems.
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Imaging System
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.
Part of a larger recall action
This product is one of 2 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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