Health product recall

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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