510(k) K131872 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
| Applicant | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Boeblingen, Baden-Wuerttemberg, DE |
| Decision | Substantially Equivalent, Oct 17, 2013 |
| Received | Jun 24, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131872
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX500. Product Number: 866064. Open, Classified |
MHX | None listed |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX550. Product Number: 866066. Open, Classified |
MHX | None listed |
| Oct 4, 2024 | Philips North America Llc IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:
1) IntelliVue MX400 866060;
2) IntelliVue MX450 866062;
3) Open, Classified |
MHX | None listed |
| Sep 25, 2024 | Philips North America IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066) Open, Classified |
MHX | None listed |
| Jul 26, 2016 | Philips Electronics North America Corporation IntelliVue Patient Monitor
Product Usage:
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.