| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00418-1 |
| Product Name/Description |
ICS G2 Clinical Access (used for acquiring 24-72 hours of standard patient waveforms for analysis)
CD PN: 063-1829-11 Rev A
Model: 91810
ARTG Number: 128816 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
7/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
There is a defect in the ICS G2 Clinical Access Software CD. The programs installed on the Clinical Access CD are incorrect and will prevent the user from installing Clinical Access. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtel Australia is requesting their customers to dispose of CD: PN 063-1829-11 Rev A and replace with Rev B. The replacement CD will be delivered to all relevant departments of the hospital by a Medtel service engineer. |
| Contact Information |
1300 886 385 - Medtel Customer Support |