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.
FDA Recall Z-1693-2019 · Posted None
Advertisement
Recalling FirmPhilips North America, LLC
Recall StatusOpen, Classified
Product CodeDSI
Date Initiated2019-03-28
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 .
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Worldwide distribution - US Nationwide and to 71 countries.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement