Recall Z-1478-2009 ยท HGM System, Monitoring, Perinatal
Philips Healthcare Inc.
Philips Avalon Fetal Monitor FM20; Model Number: M2702A.
| Date | Jun 26, 2009 (initiated May 12, 2009) |
| Status | Terminated |
| Reason | Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions |
| Root cause | Software change control |
| Action | Philips Healthcare issued an "Urgent-Medical Device Correction" notification dated May 15, 2009 to Customers in the United States via UPS and notifications outside the US will be managed by Philips representatives in each affected geography. Customers were asked to follow the guidelines in the Action to be Taken by Customer/User section of the Correction Notice until they receive their software upgrade. Questions can be made to Philips response center at 1-800-722-9377. |
| Quantity | 5,663 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071800 | PHILIPS AVALON FETAL MONITORS FM20 AND FM30 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Sep 27, 2007 |