—#171236

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.

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot 2018-28

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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

Timeline

Recall initiated: 2019-01-25
Terminated: 2020-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171236. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.