Z-2508-2024Class II

IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060...

Name: Z-2508-2024 IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060...
Creator: Philips North America Llc
Published: 2024-06-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-06-28 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for... on 2024-06-28. FDA classified it as Class II and gives the reason as "Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the...". 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-2508-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-28
Posted: 2024-08-05
Recalling firm: Philips North America LLC
Product: IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Root cause tag: software
FDA root cause: Software design
Action: Philips North America issued URGENT Medical Device Correction on 6/25/24 to End-Users. Philips Market Organizations will distribute the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Use only default measurement capabilities, as indicated in Table 1 above, for monitoring purposes. Pass this notice to all those who need to be aware within your organization or to any organization where affected devices have been potentially transferred. A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will reload the current device software to enable missing options (MOS, M06, M20). If you need any further information, please contact your local Philips representative or call 1-800-722-9377.
Quantity in commerce: 4 units
Distribution: Nationwide Foreign: Australia Austria Bangladesh Brazil Canada Chile China Colombia Denmark France Germany Hong Kong India Indonesia Italy Japan Netherlands Portugal Singapore South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand United Kingdom Vietnam
Product codes and lots: UDI: 00884838038752

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2508-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2508-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-05
Z-2509-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-05
Z-2510-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-05
Z-2511-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-05

Product code MHX

K130849Class IIIntellivue Patient Monitor Mx400; Intellivue Patient Monitor Mx450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN / cleared 2013-06-14

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)