Product Wiki · Recalls · Health Canada — Medical Devices

DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM (2016-06-09) — recall 55142

Health Canada — Medical Devices · Canada · 2016-06-30 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55142
Date of alert
2016-06-30
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: A small area on the bore surface, which is 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. No injury has been reported to GE as a result of this issue. This issue has been observed only in the rare situation in which a user has routinely used the system for off center imaging with large patients (for example, off center wrist or shoulder exams) with transmit gain set near maximum levels.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/discovery-mr750w-30t-magnetic-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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