Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A.
FDA device recall Z-0549-2010 · posted 2009-12-17 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- 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
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HGM
- Quantity affected
- 10,128 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
- Date initiated
- 2009-11-23
- Date posted
- 2009-12-17
- Date terminated
- 2020-07-30
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS AVALON FETAL MONITORS FM20 AND FM30 (K071800) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-09-27 |
| MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 (K062137) | Philips Medizin Systeme Boeblingen GmbH | 2006-08-24 |