ProductGuru Recalls

Official recall record

GE HealthCare OEC 9900 Elite C-arm Systems.

US FDA — Medical Devices · 2025-07-02 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2025-07-02
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
00840682114349
Brand on record
GE Medical Systems, LLC

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

Other recalls from this brand

All 62 official recall notices naming GE Medical Systems, LLC on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.