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Merlin patient care system - programmer software

Official notice

27 Jun 2022

MediumHealth Canada

An official Health Canada notice concerns Merlin patient care system - programmer software. 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 Published 2022-06-27.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64306

Official notice

2022-06-27

The hazard

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

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

64306

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Affected products

Product 1

Affected products - Merlin Patient Care System - Programmer Software, Lot or serial number - version v25.3.x or earlier, Model or catalogue number - 3330 VER 25.2.4 3330 VER 24.4.4 3330 VER 18.2 3330 VER 24.6.4 3330 VER 24.3.4 3330 VER 17.2.1 3330 VER 23.0.4 3330 VER 25.0.4 3330 VER 25.3.4 3330 VER 24.2.4 3330 VER 20.0.1.2 3330 VER 24.5.4

Risk / hazard

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

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

Brand: St Jude Medical Cardiac Rhythm Management Division, Merlin Patient Care System - Programmer Software.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64306

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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