Recall Z-1707-2017 ยท DSI Detector And Alarm, Arrhythmia
Philips Electronics North America Corporation
Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and
| Date | Mar 6, 2017 |
| Status | Terminated |
| Reason | Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete] |
| Root cause | Software design |
| Action | Philips issued Field Safety Notice on 3/6/17. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer .Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: When a No Data Tele INOP alert is displayed on a Philips IntelliVue Information Center iX (PIIC iX), check the MX40 as directed in the PIIC iX B.01 IFU, page 87. If the MX40 is in the Coverage Area, remove the battery, and reinsert the battery. If the MX40 is not in the Coverage |
| Quantity | 2648 |
| Distribution | Worldwide Distribution - US Nationwide including the countries of: Australia Belgium Canada Denmark Finland France Germany Germany India Italy Netherlands Norway Qatar Singapore South Africa Sweden Switzerland United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113125 | INTELLIVUE MX40 PATIENT MONITOR Philips Medical Systems, Nov 17, 2011 |