IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - 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.
- Company
- Philips North America, Llc
- Recall Initiated
- March 28, 2019
- Recall Number
- Z-1693-2019
- Firm Location
- Andover, MA
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
Worldwide distribution - US Nationwide and to 71 countries.
Lot / Code Info
All revision B.X versions are affected.
Root Cause
Software design
Action Taken
On March 28, 2019, Philips Healthcare distributed URGENT MEDICAL DEVICE RECALL notices (FSN 86201863A) dated March 22, 2019 to customers via courier service. Actions To Be Taken by Customer/User at the time was as follows: - MX4O monitors can continue to be used while awaiting a software upgrade. - Customers should maintain an adequate supply of fully charged batteries given the approximately 25% increased power consumption. Switch to continuous or manual SO2 measurements if your unit is using automatic measurement mode. On April 24, 2019, Philips Healthcare distributed UPDATE URGENT MEDICAL DEVICE RECALL notices (FSN86201863B) dated April 16, 2019 to customers via courier service. Actions To Be Taken by Customer/User is currently as follows: Until you have upgraded the software on your MX4Os, replace your batteries every 8 hours, unless you are using continuous monitoring mode and Sp02 monitoring with AA batteries, in which case replacement should be done every 2 hours. Philips Healthcare will release a software upgrade, which will correct this problem. Philips will contact you to arrange for software correction. If you need any further information or support concerning this issue please contact your local Philips representative or Philips Customer Support at 1-800- SUPPORT 722-9377.