System, Monitoring, Perinatal

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-06-22Open, ClassifiedProcess control

  Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

  Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

• 2026-06-22Open, ClassifiedProcess control

  Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

  Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

• 2026-01-22Open, ClassifiedDevice Design

  Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

• 2026-01-22Open, ClassifiedDevice Design

  Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

• 2026-01-22Open, ClassifiedDevice Design

  Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

• 2024-06-28Open, ClassifiedComponent change control

  Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.

  Potential for inaccurate fetal heart rate measurements when monitoring multiples.

• 2014-10-21TerminatedSoftware Design Change

  Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.

  Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

• 2013-11-18TerminatedSoftware design

  Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.

  1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) When

• 2009-12-17TerminatedProcess design

  Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A.

  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

• 2009-12-17TerminatedProcess design

  Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A.

  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