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510(k) K151681 · DSI Detector And Alarm, Arrhythmia

IntelliVue Patient Monitor

Applicant	Philips Medizin Systeme Boeblingen GmbH, Boeblingen, DE
Decision	Substantially Equivalent, Jul 17, 2015
Received	Jun 22, 2015
Type	Special
FDA record	Open on fda.gov

Recalls that name K151681

Date	Firm and product	Code	Linked 510(k)
Dec 2, 2025	Philips North America Llc IntelliVue MP40. Product Number: M8003A. Open, Classified	DSI	None listed
Dec 2, 2025	Philips North America Llc IntelliVue MP50. Product Number: M8004A. Open, Classified	DSI	None listed
Dec 2, 2025	Philips North America Llc IntelliVue MP60. Product Number: M8005A. Open, Classified	DSI	None listed
Dec 2, 2025	Philips North America Llc IntelliVue MP70. Product Number: M8007A. Open, Classified	DSI	None listed
Dec 2, 2025	Philips North America Llc IntelliVue MP80. Product Number: M8008A. Open, Classified	DSI	None listed
Dec 2, 2025	Philips North America Llc IntelliVue MP90. Product Number: M8010A. Open, Classified	DSI	None listed
Oct 1, 2024	Philips North America IntelliVue G7m Anesthesia Gas Module, Product Number 866173 Open, Classified	DSI	None listed
Jun 25, 2020	Philips North America, LLC IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173 Open, Classified	MHX	None listed

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