MyCareLink Relay Home Communicator

Official notice

14 Sept 2020

Last checked

14 Sept 2020

High riskACCC

An official ACCC notice concerns MyCareLink Relay Home Communicator. If incomplete or misleading information is used to make treatment decisions this may lead to insufficient/inappropriate medical intervention causing serious health implications. Published 2020-09-14.

What to do now

Medtronic will contact affected users in writing, by phone and by automated call messages, where Medtronic network logs indicate a lack of connectivity after July 17, 2020. Consumers are instructed to power cycle the monitor to update the communication protocols. If the user has already completed a power cycle after July 17 they do not need to take any action. For further information, please contact Medtronic Customer Service by phone on 1800 644 128.

Recall number

460c2d50-ee14-4c3c-ae2e-f7439ee46c2f

Official notice

2020-09-14

The hazard

If incomplete or misleading information is used to make treatment decisions this may lead to insufficient/inappropriate medical intervention causing serious health implications.

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.

Artg Numbers

313825

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Affected products

Product 1

MyCareLink Relay Home Communicator Product code: 24960 All serial numbers The MyCareLink Relay Home Communicator sends data from an implanted heart device to medical clinicians. ARTG 313825 (Medtronic Australasia Pty Ltd - Cardiac pulse generator reader, home-use)

Risk / hazard

If incomplete or misleading information is used to make treatment decisions this may lead to insufficient/inappropriate medical intervention causing serious health implications.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

ELECTRONICS

Classification

Pharmacy and medical products, Smart and interconnected devices

App estimate

high

Recall details

Recall number

460c2d50-ee14-4c3c-ae2e-f7439ee46c2f

Classification

Pharmacy and medical products, Smart and interconnected devices

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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