Recall MonitorHealth Products
BK Medical Ultrasound Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology, Health products - Medical devices - Anaesthesiology
Product: BK Medical Ultrasound Systems
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Ultrasound Scanner Flex Focus - Main Unit | More than 10 numbers, contact manufacturer. | 1202 |
| bkActiv Ultrasound System | 2007497 | 2300 |
| bkActiv Ultrasound System | 2007609 | 2300 |
| bkActiv Ultrasound System | 2008878 | 2300 |
| bkActiv Ultrasound System | 2007478 | 2300 |
| bkActiv Ultrasound System | 2005278 | 2300 |
| bkActiv Ultrasound System | 2007610 | 2300 |
| bkActiv Ultrasound System | 2006358 | 2300 |
| bkSpecto Ultrasound System 1300 | More than 10 numbers, contact manufacturer. | 1300 |
| Ultrasound Scanner System 2300 - Main Unit | More than 10 numbers, contact manufacturer. | BK3500 |
| Ultrasound Scanner System 2300 - Main Unit | More than 10 numbers, contact manufacturer. | BK3000 |
| bk5000 Ultrasound System - Main Unit | More than 10 numbers, contact manufacturer. | 2300 |
Issue
The instructions for use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.