—#86827

Product

Philips Avalon Fetal Monitor FM 50 Catalog Number: M2705A.

FDA product code: HGM — System, Monitoring, Perinatal
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: All serial numbers.

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Nationwide (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 French Guiana Gabon Germany Greece Guadeloupe Guatemala Hong Kong Hungary Iceland India Indonesia Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Libyan Arab Jamahiriya Lithuania Luxembourg Macau Malaysia Martinique Mauritius Mexico Moldova Morocco Namibia Netherlands Netherlands Antilles New Caledonia New Zealand Norway Oman Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Qatar Reunion Romania Russia Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Turks and Caicos Islands Ukraine United Arab Emirates United Kingdom Uzbekistan Venezuela Viet Nam Zambia

Timeline

Recall initiated: 2009-11-23
Posted by FDA: 2009-12-17
Terminated: 2020-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86827. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.