The Recall Desk

FDA (Devices) recall action 81077

GE Healthcare, LLC recalled 5 products on 2018-12-19

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2018-12-19
Critical
0
Units
79,907

Why these products were recalled

Patient monitors may restart due to network overload caused by network configuration.

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.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2018-12-19

    GE Healthcare Recalls B40i Patient Monitors Due to Network Restart Risk

    GE Healthcare is recalling 6,864 B40i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and duri
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-12-19

    GE Healthcare Recalls B20i Patient Monitors Due to Network Overload Restart Risk

    GE Healthcare is recalling 6,458 B20i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and dur
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-12-19

    GE Healthcare Recalls PROCARE B20 Patient Monitors Due to Network Issues

    GE Healthcare is recalling 28,004 PROCARE B20 patient monitors because network configuration issues may cause the devices to restart unexpectedly.

    Product
    PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hos
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-12-19

    GE Healthcare Recalls B105/125 Patient Monitors Due to Network Overload Risk

    GE Healthcare is recalling 5,516 B105/125 patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital trans
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-12-19

    GE Healthcare Recalls PROCARE B40 Patient Monitors Due to Network Overload Risk

    GE Healthcare is recalling 33,065 PROCARE B40 patient monitors because network configuration issues may cause the devices to restart unexpectedly.

    Product
    PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal pat
    Category
    Distribution
    1 state