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Type of Product	Medical Device
TGA Recall Reference	RC-2020-RN-01541-1
Product Name/Description	Infinity Acute Care Systems and Infinity M540 Stand Alone Patient Monitors Product code: MS20401 software version VG4.1.1 and lower ARTG 168054 (Draeger Australia Pty Ltd - Patient monitor, multiparameter) ARTG 98600 (Draeger Australia Pty Ltd - Patient monitor, multiparameter, transportable)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	4/01/2021
Responsible Entity	Draeger Australia Pty Ltd
Reason/Issue	The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The Infinity M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring. This issue was observed during post market activities and there were no reported cases of patient impairment.
Recall Action	Product Defect Correction
Recall Action Instructions	Draeger are in the process of resolving this product issue and customers will be provided with an updated software version as soon as it becomes available (release envisaged late January/early February2021). On release, a Draeger service representative will contact users regarding the upgrade for the affected Infinity Acute Care Systems and Infinity M540 Stand Alone Patient Monitors. At that time, a Draeger service representative will schedule a visit to upgrade all affected Infinity Acute Care Systems. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	03 9244 7248 - Sue Connolly