Rappel de Device Recall Philips Avalon Fetal Monitor

Recall

53889

Class 2

Z-0552-2010

2009-11-23

2009-12-17

Completed

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86827

Potential 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.

Philips 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 a day to assist users with questions related to device use by calling 1-800-722-9377, press <3> then <1> for patient monitoring application issues and ask to speak with an application specialist. Customers will be requested to incorporate the information contained in the Urgent Medical Device Recall notice and the Addendum to the Instructions for Use with the existing Avalon labeling (Instructions for Use) provided with the product. Customers will be asked to complete an enclosed Confirmation Form indicating that they have received and disseminated this information, and then return the completed form to Philips. Questions about this field action or reports of product problems should be directed to the Philips Response Center at 1-800-722-9377.