Product Wiki · Recalls · Health Canada — Medical Devices

Zoll ventilators with MRI compatibility — recall 75636

Health Canada — Medical Devices · Canada · 2024-06-07 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75636
Date of alert
2024-06-07
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Anaesthesiology
Product type
Medical devices
Reported risk: Manufacturer is voluntarily recalling a limited number of operator's guides and quick reference guides related to Zoll ventilators with MRI compatibility. Through an internal review of product manuals, it was identified that documented patient safety ventilator MRI information was inadvertently omitted from the manual. The impacted manual only states to place the ventilator behind the 2000 gauss line. The updated language has been changed to: You must place the ventilator behind the 130 gauss field line (approximately 2 meters to the bore opening of a 3T MRI magnet). This update to the instruction ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy. Recall Start Date: May 24, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/zoll-ventilators-mri-compatibi

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