Lower risk Medical device recall · FDA · Published June 28, 2024

Philips IntelliVue Patient Monitor MX500 Software Issue Recall

Philips recalls IntelliVue Patient Monitors MX500 with L.x and M.x software versions that may not offer certain features due to incorrect entitlements, risking incorrect patient treatment.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2510-2024Medical device Philips ›

Lower-risk 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,

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips is recalling IntelliVue Patient Monitors MX500 models with L.x or M.x software versions that may not provide some features due to incorrect software entitlements. This could lead to incorrect or delayed patient treatment if the monitor fails to function properly. Read more at govinfonow.com/recall/54714-philips-intellivue-patient-monitor-mx500-software-issue-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/54714-philips-intellivue-patient-monitor-mx500-software-issue-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2510-2024

Cite this page

“Philips IntelliVue Patient Monitor MX500 Software Issue Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54714-philips-intellivue-patient-monitor-mx500-software-issue-recall. Based on FDA recall #Z-2510-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2510-2024%22&limit=1).

The FDA announced on June 28, 2024, that Philips North America LLC is recalling IntelliVue Patient Monitor MX500 units with specific software versions due to incorrect software options. The hazard involves potential incorrect or delayed treatment for patients. Owners should contact Philips for remedy details.

How to tell if you have it

Brand: Philips
Product: IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements
Model Number: 866064
Quantity: 18 units

The hazard

Philips states that changes to reflect options becoming standard for software-version N.x resulted in the removal of entitlements for software options MOS, M06, and M20 for software versions L.x and M.x. Consequently, monitors with these software versions will not offer the expected capabilities. This issue may also affect monitors with software version K.x provided with L.x entitlements. The potential hazard is incorrect or delayed treatment for the patient.

Context

GovInfoNow's records show Philips North America LLC has 129 other recalls on record since July 12, 2017. Recent recalls include an August 21, 2026 recall of Ingenia Ambition S and X models for software issues terminating examinations and an August 18, 2026 recall of Spectral CT 7500 Scanners for potential extra radiation exposure. Other recent recalls of similar products include a July 31, 2026 recall of Philips PIC iX Essentials Software for patient data issues and a July 20, 2026 recall of GE Medical Systems Portrait Compute V1.2 Software for patient monitoring risk.

How to tell if you have this one

Check for the model number 866064 on the monitor. The software version is L.x or M.x for affected units, which may not provide all features due to incorrect entitlements.

Brand
Philips
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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

Recall number	Product, codes & lots	Quantity
Z-2508-2024	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.; UDI: 00884838038752	4 units
Z-2509-2024	IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. 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.; UDI: 00884838038769	49 units
Z-2510-2024	IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. 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.; UDI: 00884838038776	18 units
Z-2511-2024	IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. 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.; UDI: 00884838038783	9 units US

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify the software version on your monitor; affected units have L.x or M.x versions.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 47 days after the firm started it.

Jun 28, 2024Firm started the recall
Aug 5, 2024FDA classified it Class II
Aug 14, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Philips recalls

Link to this recall

<a href="https://govinfonow.com/recall/54714-philips-intellivue-patient-monitor-mx500-software-issue-recall">Philips IntelliVue Patient Monitor MX500 Software Issue Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2510-2024 (June 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2510-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.