Recall Z-0104-2015 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Medical Systems, Inc.
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
| Date | Oct 21, 2014 (initiated Oct 3, 2014) |
| Status | Terminated |
| Reason | Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped |
| Root cause | Software Design Change |
| Action | Philips Healthcare issued on 10/3/14 the Urgent Medical Device Correction notification/Field Safety Notice. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a software upgrade free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medic |
| Quantity | 7587 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLO |
| FDA record | Open on fda.gov |