Home / Recalls / Philips North America Llc / Z-1107-2025

Z-1107-2025 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
February 12, 2025
Initiation Date
January 15, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28 units

Product Description

IntelliVue Patient Monitor MX400. Model Number: 866060

Reason for Recall

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Distribution Pattern

US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Code Information

Model Number: 866060. UDI-DI Number: (01)00884838038752(21). Serial Numbers: DE35174105, DE35174084, DE35174083, DE35174082, DE35174080, DE35107369, DE35108320, DE35160410, DE671M4116, DE7770DA9W, DE35114616, DE35114618, DE671E8921, DE671E8917, DE7580AH50, DE7580AHEH, DE35123130, DE671V9297, DE671V9296, DE671V9298, DE35160989, DE35160994, DE35160988, DE35161272, DE35161273, DE35161274, DE7580B537, DE7580B52H.

Other recalls by Philips North America Llc

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  • Z-1964-2026 Class II — Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. (April 14, 2026)
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  • Z-1953-2026 Class II — Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7812 (April 14, 2026)