Recall Z-1671-2021 ยท DSI Detector And Alarm, Arrhythmia
Philips North America Llc
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.
| Date | Feb 2, 2021 |
| Status | Terminated |
| Reason | Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices |
| Root cause | Employee error |
| Action | Philips Healthcare conducted site visits on 2/02/21 by Field Service Engineer and provided the customer with RMA to return affected devices. Devices retuned affected device on RMA. Device Replacement provided. |
| Quantity | 3 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113125 | INTELLIVUE MX40 PATIENT MONITOR Philips Medical Systems, Nov 17, 2011 |