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Health Canada Medical devices

Bk3000/3500, Bk5000 and Bkactiv Ultrasound Systems

Issued September 19, 2024
Issue
BK medical, a GE Healthcare Company, 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. Recall Start Date: September 11, 2024
Hazard description
Performance
Product
Product name
Bk3000/3500, Bk5000 and Bkactiv Ultrasound Systems
Reference
ID
RA-76056