MyCareLink Relay Home Communicator
Reason for Recall / Hazard
A software update on 17 July 2020 caused a data connectivity disruption to the MyCarelink software. As a result data transmissions, including CareAlerts, are disabled between the Communicator and the CareLink Network. This issue results in the inability for a Relay communicator to transmit implanted device data to the CareLink Network and persists until the Relay is power cycled for any reason. There is no impact to users implanted device or data from that device.
Product Description & Identification
Reason / Defects: A software update on 17 July 2020 caused a data connectivity disruption to the MyCarelink software. As a result data transmissions, including CareAlerts, are disabled between the Communicator and the CareLink Network. This issue results in the inability for a Relay communicator to transmit implanted device data to the CareLink Network and persists until the Relay is power cycled for any reason. There is no impact to users implanted device or data from that device. Hazards: If incomplete or misleading information is used to make treatment decisions this may lead to insufficient/inappropriate medical intervention causing serious health implications. What to do: 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.
Affected Products
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)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 460c2d50-ee14-4c3c-ae2e-f7439ee46c2f |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/mycarelink-relay-home-communicator |
| Pub Date | Mon, 14 Sep 2020 00:00:00 +0000 |
| Extracted image | https://www.productsafety.gov.au/system/files/styles/large/private/MyCareLink%20Relay%20Home%20Communicator_0.jpg?itok=EGwCQCv3 |
Overview
- Risk Level["Pharmacy and medical products","Smart and interconnected devices"]
- DistributionAustralia