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

Recall Z-1546-2021 — NM/CT 860 Nuclear Medicine / CT Scanners

U.S. FDA — Device Enforcement · United States · 2021-02-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1546-2021
Date of alert
2021-02-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840682140751
Reported risk: GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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