GE HealthCare OEC 9800.
Reported: September 3, 2025 Initiated: July 2, 2025 #Z-2341-2025
Product Description
GE HealthCare OEC 9800.
Reason for Recall
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, 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 missing lead tape is not detectable by the user.
Details
- Recalling Firm
- GE Medical Systems, LLC
- Distribution
- US Nationwide distribution.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE HealthCare OEC 9800.. Recalled by GE Medical Systems, LLC.
Why was this product recalled? ▼
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, 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 missing lead tape is not detectable by the user.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2025. Severity: Moderate. Recall number: Z-2341-2025.
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