Reported Oct 16, 2024 · Ongoing
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows
4 of 4 products
| Model / number | Product as published |
|---|---|
866060 | MX400 |
866062 | MX450 |
866064 | MX500 |
866066 | MX550 |
- Lot codes and dates
- UDI-DI
(01)00884838038769(21)(01)00884838038776(21)(01)00884838038783(21
- Serial Numbers
153 of 153 codes
DE7580BB1YDE7580BB1ZDE7580BB20DE7580BB21DE7580BB22DE7580BB23DE7580BB24DE7580BB25DE7580BC47DE7580BC48DE7580BC4LDE7580BC4MDE7580BC4NDE7580BC4PDE7580BC4TDE7580BC4UDE7580BC5KDE7580BC5LDE7580BC5NDE7580BC5PDE7580BC5RDE7580BC5TDE7580BC5UDE7580BC5VDE7580BC68DE7580BC69DE7580BC6ADE7580BC6BDE7580BC6CDE7580BC6DDE7580BC6EDE7580BC6RDE7580BC6ZDE7580BC8RDE7580BCV4DE7580BD4KDE7580BD4LDE7580BF3ZDE7580BFULDE7580BFUMDE7580BFUNDE7580BFWYDE7580BJM2DE7580BJM3DE7580BJM4DE7580BJM5DE7580BJM6DE7580BJM7DE7580BJWVDE7580BJWWDE7580BJWYDE7580BJWZDE7580BJY0DE7580BJY1DE7580BK55DE7580BK56DE7580BK75DE7580BK76DE7580BK77DE7580BK78
- UDI-DI
- Amount recalled
- 153 units OUS
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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