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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