| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00618-1 |
| Product Name/Description |
AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)
Product Code: AVOX1000E
Serial Numbers: 5696-5725, 5816-5977
ARTG Number: 262420 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Accriva Diagnostics has confirmed that some AVOXimeter 1000E instruments shipped to customers from July 2015 and April 2016 may have been sent to customers with the diagnostic mode enabled.
With the diagnostic mode enabled, users could mistakenly unlock features in the instrument software through a specific sequence of keystrokes. If these features are altered, there is a potential for erroneous results to be displayed. To date Accriva has not received any reports of injuries or harm to users due to this issue. Instruments in diagnostic mode perform per Accriva’s specifications and all data generation is equivalent to those instruments properly set to user mode. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zoll Medical is providing instructions for users to be able to identify the affected instruments. In the case where an affected instrument is identified, users should contact Zoll Technical Services to correct the settings. This action has been closed-out on 03/02/2017. |
| Contact Information |
02 8424 8720 - Zoll Medical Australia |