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

Recall Z-2004-2021 — Revolution CT

U.S. FDA — Device Enforcement · United States · 2021-03-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2004-2021
Date of alert
2021-03-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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