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

Recall Z-0023-2014 — GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.

U.S. FDA — Device Enforcement · United States · 2013-03-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0023-2014
Date of alert
2013-03-26
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 recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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