Z-1067-2019Class II

Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 -

Name: Z-1067-2019 Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 -
Creator: Philips North America, LLC
Published: 2019-01-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-01-25 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals... on 2019-01-25. FDA classified it as Class II and gives the reason as "Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor". 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-1067-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-25
Posted: 2019-03-28
Terminated: 2020-04-21
Recalling firm: Philips North America LLC
Product: Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX40 is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center, the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center. The MX40 can provide time-limited local monitoring when it is not connected to the wireless network.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Philips issued an email on January 25, 2019 informing customers the batteries on hold had been inadvertently shipped. Philips is asking customers to follow the Action to be Taken by Customer/User should check all MX40s that may contain an affected battery, immediately remove any affected batteries found and replace them with unaffected batteries. The batteries should be returned with the RMA number and return label provided by Philips following any special requirements for shipping lithium-ion batteries specified by the carrier they select
Quantity in commerce: 40
Distribution: US Nationwide distribution in the states of AK, CA, CO, IN,MI, NC, ND, NM, OR, TN, TX and UT.
Product codes and lots: Lot 2018-28

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1067-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1067-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-28

Product code MHX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)