Z-1694-2019 Class II Ongoing
FDA device recall Z-1694-2019 was initiated by Philips North America, LLC on March 28, 2019 and is designated Class II. Reason for recall: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State . The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- March 28, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: 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.
Reason for Recall
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Distribution Pattern
Worldwide distribution - US Nationwide and to 71 countries.
Code Information
All revision B.X versions are affected.