| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00348-1 |
| Product Name/Description |
Zoll X Series Defibrillators with system software version 02.10.02.00 or higher
ARTG Number: 99437 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Zoll Medical Corporation has received 8 field reports where the device displayed an Internal Error Reset Required message and then entered a
continuous “system reset” loop. The device cannot be used if it is in a continuous system reset loop. Zoll Medical's investigation has identified a software error associated with the device's “full disclosure log.” The error may occur during specific conditions, and in particular when the full disclosure log reaches its memory capacity (150 cases) due to invalid data in the overwriting of a full disclosure log. The probability of having an event is low under normal operating conditions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers who are having devices with the affected software versions are advised to immediately erase the device full disclosure log per the instructions provided in the customer letters. Users should continue to erase the device log once/month (or before 150 cases are stored in the log) until the device software has been updated. To permanently mitigate the issue, a software upgrade pack will be provided to customers which is anticipated to be available by the week commencing March 24, 2014. |
| Contact Information |
02 8424 8720 - Zoll Medical Australia Operations Manager |