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Activa clinician programmer application for deep brain stimulation

Official notice

2 Aug 2022

Last checked

2 Aug 2022

Medium riskHealth Canada

An official Health Canada notice concerns Activa clinician programmer application for deep brain stimulation. A system error and termination of program may occur. This may occur when a patient was previously programmed with an A610 dbs clinician programmer application v.2.0.x or later, and later the same device is interrogated with a clinical programmer tablet running A610 version 3.0. 1062. Recall start date: July 26, 2022 Published 2022-08-02.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64430

Official notice

2022-08-02

The hazard

A system error and termination of program may occur. This may occur when a patient was previously programmed with an A610 dbs clinician programmer application v.2.0.x or later, and later the same device is interrogated with a clinical programmer tablet running A610 version 3.0. 1062. Recall start date: July 26, 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

64430

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Affected products

Product 1

Affected products - Activa Clinician Programmer Application For Deep Brain Stimulation, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - A610

Risk / hazard

A system error and termination of program may occur. This may occur when a patient was previously programmed with an A610 dbs clinician programmer application v.2.0.x or later, and later the same device is interrogated with a clinical programmer tablet running A610 version 3.0. 1062. Recall start date: July 26, 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: Medtronic, Activa Clinician Programmer Application For Deep Brain Stimulation.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64430

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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