Z-1107-2025Class II

IntelliVue Patient Monitor MX400. Model Number: 866060

Name: Z-1107-2025 IntelliVue Patient Monitor MX400. Model Number: 866060
Creator: Philips North America Llc
Published: 2025-01-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-01-15 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of IntelliVue Patient Monitor MX400. Model Number: 866060 on 2025-01-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1107-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-15
Posted: 2025-02-05
Recalling firm: Philips North America LLC
Product: IntelliVue Patient Monitor MX400. Model Number: 866060
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
Action: Philips began notifying consignees on about 01/15/2025 via certified letters titled URGENT Field Safety Notice and URGENT Medical Device Correction letters. Consignees were instructed to ensure that there is no interruption of the cable connection between the Hamilton ventilator and the EC10 Module or IntelliBridge I/O board before use, provide the notification to all affected personnel and customers if the devices have been further distributed, and to complete and return the response form provided. A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will upgrade your ED245 Driver from revision A.0 to revision A.1. Distributors were instructed to return the Response Form attached your contact information, send the attached URGENT Field Safety Notice to each customer to whom you have distributed any affected device as soon as possible and no later than 5 days, together with the Reply Card, perform a good faith effort to get the Response Form by following up with the customer with a minimum of three attempts, and if possible, using multiple contact methods, inform Philips about the responses received, and implement the Technical solution established by Philips as soon as available within the timeframe communicated by Philips and confirm to Philips the implementation in all affected products. In case a product is not corrected, inform Philips on the reason why the technical solution cannot be implemented.
Quantity in commerce: 28 units
Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1107-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1106-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05
Z-1107-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05
Z-1108-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05
Z-1109-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05
Z-1110-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05

Product code MHX

K082583Class IIIntellivue Patient Monitor, Intellibridge Module, Models Mp40, Mp50, Mp60, Mp70, Mp80, Mp90, Ec10, Ec5Philips Medizinsysteme Boeblingen GmbH, Cardiac AN / cleared 2009-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)