The Recall Desk

FDA (Devices) recall action 69348

Philips Medical Systems, Inc. recalled 2 products on 2014-10-29

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-10-29
Critical
0
Units
7,705

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2014-10-29

    Philips Avalon Fetal Monitors Recalled for Software Measurement Error

    Philips is recalling Avalon fetal monitors with specific software because automatic blood pressure measurements stop in certain modes.

    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-29

    Philips IntelliVue Monitors Recalled for NBP Measurement Stoppage

    Philips is recalling IntelliVue monitors with specific software revisions because the automatic blood pressure measurement series stops in time-synchronized mode.

    Product
    Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms…
    Category
    Distribution
    0 states