Health product recall

Zoll ventilators with MRI compatibility

Last updated

Summary

Product
Zoll ventilators with MRI compatibility
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Uni-Vent 731 EMV+ AY20A009538 AY20A009669 AY16J001624 AY20A009546 731 EMV+
Eagle II Portable Ventilator VCCC100515 AY17F002444 VCDC120895 AY17C002076 VCDC120882 731 EAGLE II
Z Vent AY19G008474 Z VENT

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Zoll Medical Corporation

269 Mill Road, Chelmsford, Massachusetts, United States, 01824

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75636

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