| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00169-1 |
| Product Name/Description |
IPAD Defib Pad, CU-CUA0512F (used with I-PAD NF 1200 Defibrillator)
ARTG Number: 132210 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Discrepancy exists between the voice prompt of the I-PAD NF 1200 Defibrillator (version 7.0 only) and the physical pads currently supplied:
a) The voice prompt says "Remove the white and blue packet and tear open the package across the top and remove pads".
Please note the defibrillator pad packet supplied with the unit is white and orange, not white and blue.
b) The voice prompt then says "... peel the pad completely from it's white backing".
Please note that the backing is blue for some lot numbers supplied. Note that both pads are compatible regardless of the backing colour. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
For problem a):
In order to avoid any confusion during use of the I-PAD NF 1200 Defibrillator, Device Technologies is supplying blue labels that can be placed over the orange section of the current packet. This will ensure the packet colour matches the voice prompt.
For problem b):
Device technologies is advising that both pads are compatible regardless of the backing colour. Device Technologies will contact affceted customers when new pads are available to match the voice prompt. |
| Contact Information |
02 9975 5755 - Device Technologies |