| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00323-1 |
| Product Name/Description |
STERIS Caviwave Pro Ultrasonic Cleaning System
(used to wash instruments and accessories prior to final disinfection and sterilisation)
Product codes: ST-CRP1172 and ST-CRP1172401
ARTG number: 158370 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
STERIS has learned through customer feedback and field service experience that should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, it is possible that the circulation pump or ultrasonic generator may stop functioning. The machine does not provide an alert notifying the user of this device malfunction.
No injuries or adverse health outcomes have been reported due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies representative will contact customers to arrange an upgrade to correct the problem. Customers may continue to operate all Caviwave Pro Ultrasonic Cleaning System and are advised that if they experience a malfunction prior to the upgrade, the equipment in the cycle should be reprocessed. This action has been closed-out on 19/08/2016. |
| Contact Information |
1300 338 423 - Device Technologies |