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510(k) K113125 · DSI Detector And Alarm, Arrhythmia

INTELLIVUE MX40 PATIENT MONITOR

Applicant	Philips Medical Systems, Andover MA, US
Decision	Substantially Equivalent, Nov 17, 2011
Received	Oct 24, 2011
Type	Special
FDA record	Open on fda.gov

Recalls that name K113125

Date	Firm and product	Code	Linked 510(k)
Oct 8, 2024	Philips North America Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1 Open, Classified	DSI	None listed
Feb 2, 2021	Philips North America Llc IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple Terminated	DSI	None listed
Mar 28, 2019	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 Intel Open, Classified	DSI	None listed
Mar 28, 2019	Philips North America, LLC IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467 Open, Classified	DSI	None listed
Mar 28, 2019	Philips North America, LLC IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a t Open, Classified	DSI	None listed
Mar 28, 2019	Philips North America, LLC IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the Open, Classified	DSI	None listed
Oct 10, 2018	Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological par Open, Classified	DSI	None listed
Apr 30, 2018	Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350 Terminated	DSI	None listed
Apr 30, 2018	Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351 Terminated	DSI	None listed
Apr 30, 2018	Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352 Terminated	DSI	None listed
Apr 30, 2018	Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146 Terminated	DSI	None listed
Mar 6, 2017	Philips Electronics North America Corporation Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, Terminated	DSI	None listed
Sep 19, 2016	Philips Electronics North America Corporation Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262 Terminated	MHX	None listed
Sep 19, 2016	Philips Electronics North America Corporation Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 4535642 Terminated	MHX	None listed
Sep 19, 2016	Philips Electronics North America Corporation Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part Terminated	MHX	None listed
Jun 10, 2014	Philips Medical Systems, Inc. IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 Terminated	MHX	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.