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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00724-1
Product Name/Description Organ Care System (OCS) Heart system - OCS Heart Console

OSC Heart Console Reference Number: 1200

Serial Numbers: 2486-1-15132, 2486-1-15129, 4929-4-15182

ARTG Number: 146269
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/06/2017
Responsible Entity Transmedics Pty Ltd
Reason/Issue The manufacturer has identified a potential issue with the OCS Heart device that could affect proper operation. In particular, the blood warmer may heat beyond the set limit if the Heart Perfusion Module (HPM) is not installed in the OCS Console prior to taking the system out of Standby mode. Use of the OCS Heart device to support an organ at an elevated temperature may result in organ damage and/or turndown of organ for transplantation.
Recall Action Recall for Product Correction
Recall Action Instructions TransMedics will be correcting this issue through an update to the software and Instructions For Use (IFU). In the interim, users are to follow the directions in the Product Information Bulletin provided with the customer letter. The Bulletin describes the recommended sequence for installing the HPM into the OSC Console. In order to ensure proper performance, such as maintaining the configured blood temperature, users are to include the HPM in the system’s Self-Test by installing the HPM in the OCS Heart Console while the system is in Standby Mode.
Contact Information 02 9629 7455 - TransMedics