| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01096-1 |
| Product Name/Description |
bkActiv 2300 Ultrasound Systems 2300-56 and 2300-66
Multiple Serial Numbers
ARTG 161422
(BK Medical Australia Pty Ltd- Ultrasound system, imaging, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
If the scanning depth on the Live image is different than the Stored image, an error could result when making measurements with the system.
This issue was found during internal testing. There have been no reports of injury as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Before using the Dual Live Compare, consult the bkActiv User Manual 16-0126278, Chapter 6 – Working with the Image. When performing measurements using this feature, ensure that the scanning depth in the Live image is the same as in the Stored image.
A BK Medical representative will contact users to schedule a service visit to correct this issue.
This action has been closed out on 17/04/2024 |
| Contact Information |
02 8817 0447 - BK Medical |