Philips IntelliVue MX40 Patient Monitor Software Recall: Potential Defective Devices
Philips recalls IntelliVue MX40 Patient Monitors with specific model numbers and software versions due to manufacturing defects that could lead to potential device failure in hospital use.
Lower-risk recall
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
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What happened, in plain English
Philips is recalling certain IntelliVue MX40 Patient Monitors that may have manufacturing defects. This could lead to potential device failure during use in hospital settings, which might affect patient monitoring safety. Read more at govinfonow.com/recall/63320-philips-intellivue-mx40-patient-monitor-software-recall-potential-defective-devices.
Source Summary by GovInfoNow · govinfonow.com/recall/63320-philips-intellivue-mx40-patient-monitor-software-recall-potential-defective-devices · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1671-2021
Cite this page
“Philips IntelliVue MX40 Patient Monitor Software Recall: Potential Defective Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63320-philips-intellivue-mx40-patient-monitor-software-recall-potential-defective-devices. Based on FDA recall #Z-1671-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1671-2021%22&limit=1).
Why it’s dangerous
The recall is due to manufacturing defects that could result in the device not functioning properly. This might lead to potential failure in monitoring patient vital signs, which could impact patient safety in hospital environments.
Who’s affected
Hospital staff and patients using the IntelliVue MX40 Patient Monitors with model numbers 865350 (US) or 865352 (OUS) and software version B.06.59 are most at risk.
How to tell if you have this one
Check for model numbers 865350 (US) or 865352 (OUS) and software version B.06.59 on the device. Serial numbers listed include US09699788, US156J6219, and US156J3658.
- Brand
Philips- Product
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product- Category
Medical device
What to do — step by step
Check Device Details
Verify the model number, software version, and serial number to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Indiana, Minnesota.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1671-2021 (February 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1671-2021 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.