| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00360-1 |
| Product Name/Description |
Acuson 2000 ultrasound system (with structural foam core).
Catalogue Number: 10433816
ARTG Number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
The metal component used to engage the lock on the wheels may disconnect, preventing the user from locking and unlocking or steering the wheels.
In the event this issue occurs when the wheels are in the “unlocked” position and the user attempts to move the system, the user may lose balance. If the wheels are in the “locked” position and the user attempts to move the system, the user may sustain soft tissue damage or strain. To date, no patient injury has been reported |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising that there are no known steps the user can take to prevent the issue from occurring. Siemens will be modifying the wheel assembly on affected systems as a permanent correction. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |