| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01066-1 |
| Product Name/Description |
WATO EX-65 and A-Series (A5/A7) anaesthesia machines
Multiple Serial Numbers
ARTG Number: 158607 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Mindray has identified a potential issue related to Electrically Erasable Programmable Read-Only Memory (EEPROM) which will only occur if the system’s total number of write cycles to a particular range of memory locations has exceeded the life specification of the EEPROM. The issue will only manifest at start up or at the end of a case; it will not occur during a case. There are no adverse effects on the patient.
To date, there have been no reports of injuries associated with this issue |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The manufacturer recommeds cessation of the use of machines which have experienced this fault. Units which have not experienced the fault may be used as normal. A software upgrade is planned.
This action has been closed out on 30/10/2018 |
| Contact Information |
1800 793 011 - Mindray Customer Service |