Philips North America Llc Recall 87829
Description: IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Philips North America Llc Recall 87829 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1671-2021 |
| Event ID | 87829 |
| Event Description | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy. |
| Quantity | 3 units |
| Recall Reason | Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices |
| Device Classification | 20210602 |
| Device Code Info | Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658 |
| Center Classification Date | 20210521 |
| Recall Initiation Date | 20210202 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Visit |
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