Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Bk Medical Aps Bk3000/3500 Ultrasound Scanner System, Bk5000 Ultrasound System and Ultrasound System Bkactiv [Model or catalog Number: 2300; Lot or serial number: 2005278, 2006358] [HKMD number: 200106].
According to Health Canada, the manufacturer has become aware of an issue where the internal power connections at the power inlet of the device can come loose for bk3500, bk3000, bk5000 & bkactiv 2300 ultrasound devices with the battery option. In the unlikely event that this goes unnoticed, there is the potential for excessive heat, which could lead to a thermal event or the device becoming inoperable. There have been no injuries reported as a result of this issue.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/bk30003500-bk5000-and-bkactiv-ultrasound-systems
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Sep 2024