The Therapeutic Goods Administration (TGA), Australia issued a medical device safety alert concerning CareLink 2090 Programmer manufactured by Medtronic. The affected serial numbers are PKK010877R and PKK054660R.
Medtronic has identified that a small subset of 2090 Programmers have an incorrect software configuration for the country in which that are physically located. When a programmer is manufactured, it is configured for the region in which it will be located. In this way, Medtronic is able to differentiate the timing of software updates across different regions of the globe.
Through the investigation of this issue, a small subset of programmers have been determined to be physically located in a country outside of the region for which they are configured. Medtronic is requesting users to return affected devices for re-configuration.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01024-1
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 7 October 2013