# FDA recall Z-1067-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-01-25.

## 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.

## 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

## Distribution

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

## Key facts

- **Recall number:** Z-1067-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-25
- **Report date:** 2019-04-03
- **Termination date:** 2020-04-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1067-2019

## Citation

> AI Analytics. FDA recall Z-1067-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1067-2019. Source: US FDA. Licensed CC0.

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