Recall Z-0105-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-0105-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-03

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-10-03, terminated 2017-01-31. It names one FDA 510(k) clearance: K111083. Product: 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.. Reason: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped.

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-03
Terminated: 2017-01-31
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K111083 — PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN·cleared 2011-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.