Print version of this report
Type of Product
Medical Device
TGA Recall Reference
RC-2015-RN-01099-1
Product Name/Description
ECG Electrode
Article Number: 50007, 50547, 58046, 58051, 58198, 58205, 58688, 58789, 58872, 58995, 59356, 59629
Mulitple lot numbers affected
Recall Action Level
Hospital
Recall Action Classification
Class II
Recall Action Commencement Date
12/11/2015
Responsible Entity
Atris Pty Ltd
Reason/Issue
In response to feedback from the field, it was discovered that there is a risk ECG electrodes of specific lots fail to transmit signals. The investigations initiated confirmed the defect and permitted to identify further, potentially affected products.
This action was undertaken prior to consultation with the TGA.
Recall Action
Recall
Recall Action Instructions
Artis is advising users to decard any remaining stock.
Contact Information
1300 886 186 - Atris Pty Ltd