Recall Z-3249-2024 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
| Date | Sep 25, 2024 (initiated Aug 30, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT Medical Device Correction notification letter dated 8/30/24 was sent to customers. Actions that should be taken by the customer / user to prevent risks for patients or users " Please check if the equipotential connector is broken off (refer to Figure 1). If yes, remove the device from use. " Pass this notice to all those who need to be aware within your organization or to any organization where affected devices have been potentially transferred. " Customers should complete the URGENT Medical Device Response Form either via the QR code below or at the end of the notification to submi |
| Quantity | 545 devices |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |