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

Recall Z-2464-2012 — Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager

U.S. FDA — Device Enforcement · United States · 2012-09-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2464-2012
Date of alert
2012-09-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10276755
Reported risk: When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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