| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00534-1 |
| Product Name/Description |
Philips PageWriter TC30/50/70 Cardiographs
Product Numbers: 860306, 860310, 860315, 860429, 453564659341, 453564659351, 453564659331, 453564659321
ARTG 93460
(Philips Electronics Australia Ltd - Interpretive multichannel electrocardiograph) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/06/2023 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified that during manufacturing process, a limited number of 12-lead and 16-lead Patient Interface Modules were potentially mislabelled.
There is no impact to a patient as this issue will be detectable during installation by the biomed or the installation specialist. When the biomed personnel or the installation specialist goes to place the lead wires into the PIM, they will recognize the label markings on the PIM do not correlate to the number of leads they received, the number of connections on the PIM, or the colour of the lead labels they received. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will advise customers to contact a local Philips representative if their device is determined to be affected and Philips will replace the affected device.
This action has been closed out on 11/07/2024 |
| Contact Information |
1800 251 400 - Service delivery team - Philips |