Z-1067-2019 Class II Terminated
FDA device recall Z-1067-2019 was initiated by Philips North America, LLC on January 25, 2019 and is designated Class II. 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 The recall status is terminated (terminated April 21, 2020). Affected quantity: 40.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- January 25, 2019
- Termination Date
- April 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40
Product Description
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 Pattern
US Nationwide distribution in the states of AK, CA, CO, IN,MI, NC, ND, NM, OR, TN, TX and UT.
Code Information
Lot 2018-28