Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0705-2025 — OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiog

U.S. FDA — Device Enforcement · United States · 2024-11-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0705-2025
Date of alert
2024-11-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE OEC Medical Systems, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840682114301
Reported risk: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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