3T Heater-Cooler Devices (2019-03-10)

Starting date:

March 10, 2019

Posting date:

June 21, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70269

Last updated: 2019-06-21

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  Reason
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  Affected products

Affected Products

3T Heater-Cooler Devices

Reason

The purpose of this action it to advise users that LivaNova has initiated the roll-out in the field of a design upgrade for all 3T heater cooler devices equipped with the vacuum and sealing design solution. LivaNova is also releasing an updated version of the operating instructions for these devices.

Affected products