Product Wiki · Recalls · Health Canada — Medical Devices

GE MAGNETIC RESONANCE SYSTEMS (2015-09-01) — recall 53801

Health Canada — Medical Devices · Canada · 2015-09-29 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53801
Date of alert
2015-09-29
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The predicted Head SAR value from the modeling, when using GE Healthcare 3.0t MR scanners with the whole body RF transmit coil and receive-only surface coils for head and/or neck imaging, suggests that actual SAR delivered to the head could potentially exceed the 3.2 W/kg SAR limit defined in iec60601-2-33. This issue does not affect MR scans performed outside the head and neck areas.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ge-magnetic-resonance-systems-

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