FDA-Device2025-09-03Class II
GE HealthCare OEC 9800.
GE Medical Systems, LLC
Hazard
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.
Sold states
US Nationwide distribution.
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE HealthCare OEC 9800.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2341-2025Don't want to check this manually?
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