GE HealthCare OEC 9800.
FDA Recall #Z-2341-2025 — Class II — July 2, 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.
Recalling Firm
GE Medical Systems, LLC — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
US Nationwide distribution.
Code Information
GTIN: 00840682114349
Status
Ongoing
Voluntary / Mandated
FDA Mandated