Z-1628-2014Class II

Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for...

Name: Z-1628-2014 Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for...
Creator: Philips Medical Systems, Inc.
Published: 2014-04-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-04-04 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems, Inc. began a recall of 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... on 2014-04-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1628-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-04
Posted: 2014-05-16
Terminated: 2017-11-07
Recalling firm: Philips North America LLC
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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by 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.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1628-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1628-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-16

Product code MHX

K110622Class IIIntellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN / cleared 2011-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)