Philips North America Llc recalls IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:…
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.…
Read the official notice →- Date
- 2024-10-16
- Country
- United States
- Brand
- Philips
- Product
- IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1)…
- Classification
- Class II
- Units
- Foreign Only: Denmark France Germany Japan United Kingdom
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
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- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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