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Health Canada Medical devices

Merlin Patient Care System - Programmer Software

Issued June 27, 2022
Issue
Abbott is notifying customers of the potential for programmer software (Merlin pcs) and remote monitoring software applications (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. Pacemaker/battery functionality, therapy delivery, and longevity remain normal and within specifications. Voltage measurements and ERI (elective replacement indicator), which is based on direct voltage measurement, remain accurate. Recall start date: June 16, 2022
Hazard description
Performance
Product
Product name
Merlin Patient Care System - Programmer Software
Reference
ID
RA-64306