FDAClass IIMay 28, 2014

Lithium Ion Battery M4605A and M4607A for use with recall

Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate…

Why was Lithium Ion Battery M4605A and M4607A for use with recalled?

The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Patient Monitor Product numbers M3002A, M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8027A, M8001AU, M8002AU, M8003AU, and M8004AU with software releases up to and including G.0.

Product
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate…
Recalling firm
Philips Medical Systems, Inc.
Quantity
188,520 devices
Distribution
Worldwide Distribution - Including US Nationwide, Canada, Czech Republic, Denmark, Netherlands, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Kazakhstan, Norway, Poland, Romania, Russia, China, Slovakia, Sweden, and Turkey.
Recall date
May 28, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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