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
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
3T Heater-Cooler Devices
Lot or serial number
All lots.
Model or catalog number
16-02-81
16-02-82
16-02-85
Companies
- Manufacturer
-
Livanova Deutschland GmbH
Lindberghstrasse 25
Munich
80939
GERMANY