Device product
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Z-3249-2024
Product summary
- Event
- Event 95295
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 545 devices
- Official record key
device-enforcement:Z-3249-2024
Official wording
Reason: During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
Code information: IntelliVue Patient Monitor MX400, 866060, UDI-DI: 00884838038752; IntelliVue Patient Monitor MX430, 866061, UDI-DI: 00884838057562; IntelliVue Patient Monitor MX450, 866062, UDI-DI: 00884838038769; IntelliVue Patient Monitor MX500, 866064, UDI-DI: 00884838038776; IntelliVue Patient Monitor MX550, 866066, UDI-DI: 00884838038783; Only MX400-550 devices shipped after 26-April-2024 are affected. Please refer to the manufacturing date on the back of your monitor.
Distribution pattern: US Nationwide. Global Distribution.
Derived failure modes
-
Unknown
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.