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Health Canada Medical devices

HEARTMATE TOUCH COMMUNICATION SYSTEM

Issued November 5, 2021
Issue
Abbott has initiated customer communication following receipt of complaints of the Heartmate touch communication system ('Heartmate Touch') application ('APP') unexpectedly closing or failing to open, which will require the medical facility to have in addition at least one system monitor II. The Heartmate Touch is part of the Heartmate 3 and Heartmate II IVAS and is used in the medical facility for patient monitoring and system programming. There have been no reports of patient injury associated with these complaints. Recall date: 2021-10-25
Hazard description
Software defect
Product
Product name
HEARTMATE TOUCH COMMUNICATION SYSTEM
Reference
ID
RA-63555