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

Recall Z-3279-2018 — Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (549946

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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3279-2018
Date of alert
2018-06-06
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)
0910274040
Reported risk: GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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