Bk3000/3500, Bk5000 and Bkactiv Ultrasound Systems
Brand(s)
Last updated
Summary
Product
Bk3000/3500, Bk5000 and Bkactiv Ultrasound Systems
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Bk3000/3500 Ultrasound Scanner System | More than 10 numbers, contact manufacturer. | 2300 |
| Bk5000 Ultrasound System | More than 10 numbers, contact manufacturer. | 2300 |
| Ultrasound System Bkactiv | 2005278 2006358 | 2300 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Health products - Medical devices - Anaesthesiology
Companies
Bk Medical Aps
Mileparken 34, Herlev, Copenhagen, Denmark, 2730
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76056
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