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

Recall Z-1977-2015 — GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

U.S. FDA — Device Enforcement · United States · 2015-05-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1977-2015
Date of alert
2015-05-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2192632121
Reported risk: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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