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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00514-1
Product Name/Description	Lithium Ion Batteries, M4605A and M4607A for use with IntelliVue Patient Monitors Model numbers of the affected patient monitors :MP2, X2, MP5, MP20, MP30, MP40, MP50 Product numbers: M3002A, M8102A, M8105A, M8105AT, M8001A, M8002A, M8003A, M8004A ARTG Number: 94238
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/05/2014
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	On-going monitoring of quality data by the manufacturer has determined that the risk of battery failure increases with age, when a battery remains in use longer than 3 years after the date of manufacture or 500 charge-discharge cycles. Such failure may result in overheating. Battery management and safety practices information for the batteries M4605A / M4607A are not clearly documented in the Instructions for Use for IntelliVue Patient Monitors with software releases up to and including G.0. Overheating of the battery may cause the battery to ignite or explode, which may result in injury to a patient or user.
Recall Action	Recall for Product Correction
Recall Action Instructions	Philips is initiating this correction to provide an Addendum to the Instructions for Use for IntelliVue Patient Monitors with software releases up to and including G.0. The addendum describes that batteries M4605A / M4607A should be replaced after 3 years of continuous use after date of manufacture or 500 battery charge-discharge cycles. The addendum to the IntelliVue Patient Monitor IFU is included with the customer letter. This action has been closed-out on 10/02/2016.
Contact Information	1800 251 400 - Philips Customer Care Centre