The Recall Desk

FDA (Devices) recall action 81075

GE Healthcare Finland Oy recalled 2 products on 2018-10-17

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
2018-10-17
Critical
0
Units
106,937

Why these products were recalled

When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

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

  • ModerateFDA (Devices)··2018-10-17

    GE Healthcare CARESCAPE Monitor B450 Recalled for Network-Related Restart Issues

    GE Healthcare is recalling CARESCAPE Monitor B450 units because they may restart simultaneously and fail to complete the process if connected to an overloaded network.

    Product
    GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthc
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-10-17

    GE Healthcare CARESCAPE Monitor B850 Recalled for Network-Related Restart Issues

    GE Healthcare is recalling CARESCAPE Monitor B850 units because they may simultaneously restart during prolonged network overload, preventing the restart from completing until the network issue is corrected.

    Product
    GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facili
    Category
    Distribution
    0 states