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Health Canada Medical devices

Zoll ventilators with MRI compatibility

Issued June 7, 2024
Issue
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
Hazard description
Labelling and packaging
Product
Product name
Zoll ventilators with MRI compatibility
Reference
ID
RA-75636