CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report

Lithium-ion Rechargeable Batteries recalled by Philips North America

Philips North America is recalling Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor, distributed nationwide in the US. The recall was initiated on 25 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 2018-28

Quantity recalled40

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1067-2019
FDA event ID: 82264
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 25 Jan 2019
FDA classified: 28 Mar 2019
Reported: 3 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

25 Jan 2019	Recall initiated by company
28 Mar 2019	Classified by FDA	+62 days
3 Apr 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the states of AK, CA, CO, IN,MI, NC, ND, NM, OR, TN, TX and UT.

Nationwide Alaska California Colorado Indiana Michigan North Carolina North Dakota New Mexico Oregon Tennessee Texas Utah

Questions about this recall

Is Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor recalled?

Yes. Philips North America recalled Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor on 25 Jan 2019. The recall is Class II and its status is Terminated. Recall number Z-1067-2019.

Why was it recalled?

Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor

Which lots are affected?

Lot 2018-28

Where was it sold?

US Nationwide distribution in the states of AK, CA, CO, IN,MI, NC, ND, NM, OR, TN, TX and UT.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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