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

Recall Z-0110-2019 — GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350), 1.5T SIGNA ECHOSPEE

U.S. FDA — Device Enforcement · United States · 2018-06-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0110-2019
Date of alert
2018-06-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Medical Systems, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0850270477
Reported risk: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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