Class 2 Device Recall Philips Avalon Fetal Monitor

• Date Initiated by Firm: November 23, 2009
• Date Posted: December 17, 2009
• Recall Status: Terminated on July 30, 2020
• Recall Number: Z-0552-2010
• Recall Event ID: 53889
• Product Classification: System, Monitoring, Perinatal - Product Code HGM
• Product: Philips Avalon Fetal Monitor FM 50; Catalog Number: M2705A.
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Philips Healthcare Inc.; 3000 Minuteman Road; Andover MA 01810
• For Additional Information Contact: 978-687-1501
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Process design
• Action: 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.
• Quantity in Commerce: 1,551 units
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.