IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and… Recall
Issued October 16, 2024 · Philips North America Llc
In October 2024, Philips North America Llc recalled the IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
What you should do
- 1 Stop using IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips North America Llc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Philips North America Llc
- Category
- Health
- Recall date
- October 16, 2024
- Units affected
- Not reported
- Sold at
- Foreign Only: Denmark France Germany Japan United Kingdom
- Recall number
- FDA-Z-0020-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Philips North America Llc has 34 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.