| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00803-1 |
| Product Name/Description |
V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation Systems
Manufactured between 2 January 2014 and 2 May 2016
ARTG Number: 154905 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
STERIS has identified that V-PRO 1, V-PRO 1 Plus, and V-PRO maX Sterilisers manufactured after 1 January 2014 may not display the correct date as of
29 February 2016. While the V-PRO units display an incorrect date, the steriliser functions and cycle operations continue to operate properly. If users do not manually change the system date of the V-PRO unit, the unit’s display and cycle printout will contain an incorrect date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is advising users that a service technician will be upgrading all affected systems. Users are advised that the system date can be amended using the instructions found in the Operator's Manual. The system can continue to be used as normal until corrected. This action has been closed-out on 11/05/2017. |
| Contact Information |
02 8244 3721 - Device Technologies |