Recall Z-0105-2015 ยท HGM System, Monitoring, Perinatal
Philips Medical Systems, Inc.
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
| 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 | 118 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 |
510(k) clearances named in this recall
| K111083 | PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Aug 17, 2011 |