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Zoll ventilators with mri compatibility

Official notice

7 Jun 2024

Last checked

7 Jun 2024

Medium riskHealth Canada

An official Health Canada notice concerns Zoll ventilators with mri compatibility. 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 Published 2024-06-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75636

Official notice

2024-06-07

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

75636

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Affected products

Product 1

Affected products - Uni-Vent 731 EMV+, Lot or serial number - AY20A009538 AY20A009669 AY16J001624 AY20A009546, Model or catalog number - 731 EMV+

Product 2

Affected products - Eagle II Portable Ventilator, Lot or serial number - VCCC100515 AY17F002444 VCDC120895 AY17C002076 VCDC120882, Model or catalog number - 731 EAGLE II

Product 3

Affected products - Z Vent, Lot or serial number - AY19G008474, Model or catalog number - Z VENT

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Zoll Medical, Zoll Ventilators With Mri Compatibility.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75636

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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