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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00993-1
Product Name/Description HeartStart XL Defibrillator Battery / Monitor, model M3516A (manual defibrillator).

Units Affected: HeartStart XL battery M3516A labelled with 'Made in Taiwan' and date of manufacture 'R-2011-12'

ARTG Number : 95661
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 26/09/2012
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue If the XL Defibrillator/Monitor (M4735A) is used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
Recall Action Recall for Product Correction
Recall Action Instructions Customers are being advised to identify whether they are using the defibrillators with a defective battery and to operate the affected HeartStart XL Defibrillator/Monitor using AC power supply only. Philips will be providing affected customers with a replacement battery(s) as soon as a new production of batteries are available.
Contact Information 1800 251 400 - Philips Customer Care Centre