ClearanceBrief
Recall Z-0550-2010 ยท HGM System, Monitoring, Perinatal

Philips Healthcare Inc.

Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A.

DateDec 17, 2009 (initiated Nov 23, 2009)
StatusTerminated
ReasonPotential for inaccurate ultra-sound derived fetal heart rate readings in Philips Avalon Fetal Monitors. Although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate monitoring, the frequency of such complaints is greater for these devices than for the previous generation Philips Series 50 fetal monitors. Clinical decisions bas
Root causeProcess design
ActionPhilips notified customers with an Urgent Medical Device Recall notice and Instructions for Use Addendum on 11/23/09 via UPS. Philips is providing the Addendum to reinforce the Avalon Instructions for Use regarding: " Recognizing these phenomena as they relate to the Avalon Fetal monitor and fetal monitors in general; and " Understanding the differences between the Philips Avalon Fetal Monitors and their predecessors, the Philips Series 50 Fetal Monitors, as they relate to the display of ultrasound-derived FHR. Philips is providing access to application specialists who are on call 24 hours
Quantity7,209 units
DistributionNationwide (US and Puerto Rico). Foreign: Afghanistan Algeria Argentina Australia Austria Bahrain Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Czech Republic Denmark Dominican Republic Ecuador Egypt El Salvador Estonia Finland France
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K052795PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
Philips Medizin Systeme Boeblingen GmbH, Dec 30, 2005
K062137MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
Philips Medizin Systeme Boeblingen GmbH, Aug 24, 2006
K071800PHILIPS AVALON FETAL MONITORS FM20 AND FM30
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Sep 27, 2007