Recall Z-1692-2019 ยท DSI Detector And Alarm, Arrhythmia
Philips North America, LLC
IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - 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 ala
| Date | Mar 28, 2019 |
| Status | Open, Classified |
| Reason | The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State . |
| Root cause | Software design |
| 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 ME |
| Distribution | Worldwide distribution - US Nationwide and to 71 countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113125 | INTELLIVUE MX40 PATIENT MONITOR Philips Medical Systems, Nov 17, 2011 |