System, Monitoring, Perinatal

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.

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.

Brand Name: EDAN

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.

Brand Name: EDAN

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.

Brand Name: EDAN

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.

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.

Philips Avalon Monitors with software revision J.30.58:

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

Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Post

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

Philips Avalon Fetal Monitor FM 20

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 Avalon Fetal Monitor FM 30

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