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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00156-1
Product Name/Description	Philips HeartStart XL+ Defibrillator / Monitor (manual defibrillator) Model Number: 861290 Serial Number ranges: USO1100100–USO1100372 US61201722–US61201924 USN1100376–USN1100960 US71201925–US71202048 USD1100961–USD1101095 US81202049–US81202168 US11201096–US11201186 US91202169–US91202514 US21201187–US21201239 USO1202515–USO1202990 US31201240–US31201537 USN1202991–USN1203537 US41201538–US41201585 USD1203538–USD1203968 US51201586–US51201721 US11303969–US11303972
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	19/02/2013
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	The Philips HeartStart XL+ Defibrillator/Monitor may fail to power on in clinical mode and instead power on in service mode, displaying an "Equipment Disabled: Therapy" prompt, requiring the user to enter a password and perform an Operational Check to clear the condition. The device will not return to clinical mode until an Operational Check has been performed.
Recall Action	Recall for Product Correction
Recall Action Instructions	A Philips representative with contact customers with affected devices to arrange for a software update. Until the correction is implemented the device can continue to be used by following work around procedures.
Contact Information	1800 251 400 - Philips Customer Care Centre