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.
FDA Recall Z-1628-2014 · Posted 2014-05-16
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Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2014-04-04
Date Terminated2017-11-07
Product Quantity188,520 devices
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.
Firm Action
Philips sent an Urgent: Medical Device Correction letter dated April 4, 2014 to all affected customers. The letter identified the affected product, problem, action to be taken and instructions for Use Addendum. Customers were instructed to review this information with all staff members who are involved in the operation and battery management of the IntelliVue patient Monitors and need to be aware of the contents of this communication. The addendum should be stored with the Monitor Instructions for Use. Please contact your local Philips representative or call us at 1-800-722-9377 with questions or concerns about this correction.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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