FDA Medical Device Recalls (openFDA)
Philips North America, LLC: 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.
- Recall number
- Z-1067-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-01-25
- Posted
- not on file
- Terminated
- 2020-04-21
- Reason
- 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
- 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
- 40
- Distribution
- US Nationwide distribution in the states of AK, CA, CO, IN,MI, NC, ND, NM, OR, TN, TX and UT.
- Lot, serial or model codes
- Lot 2018-28
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28