Recall Z-1628-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-1628-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-04

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-04-04, terminated 2017-11-07. It names one FDA 510(k) clearance: K110622. 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 alarms for, multiple physiological parameters.. Reason: 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..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-04
Terminated: 2017-11-07
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K110622 — INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN·cleared 2011-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.