The Recall Desk

FDA (Devices) recall action 94494

GE Healthcare Finland Oy recalled 5 products on 2024-07-03

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
2024-07-03
Critical
0
Units
94,531

Why these products were recalled

GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.

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.

1–5 of 5

  • HighFDA (Devices)··2024-07-03

    GE CARESCAPE Canvas monitors may lose display following power loss events

    GE Healthcare medical monitors may fail to display following a power loss event after CPU battery replacement, potentially delaying patient condition recognition.

    Product
    CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) 5865770-01055270; k) 5865770-01055317; l) 5865
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-07-03

    Patient Monitors May Fail to Display Vitals After Power Loss

    GE Healthcare is recalling certain CARESCAPE Canvas patient monitors that may fail to display vital signs after a power loss if the CPU battery has been replaced. This could delay recognition of changes in patient condition.

    Product
    CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-07-03

    CARESCAPE Patient Monitors May Not Power On After Battery Replacement

    Certain GE CARESCAPE patient monitors may fail to power on after mains power loss during battery maintenance, potentially delaying recognition of patient condition changes.

    Product
    CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2095802-001-554923, 9) 2095802-001-554924, 10) 2095802-001-554925, 11) 2095802
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-07-03

    GE CARESCAPE Monitors May Fail to Power On After Battery Replacement

    GE Healthcare recalls CARESCAPE B650 patient monitors that may fail to power on after mains power loss following CPU timekeeper battery replacement, potentially delaying recognition of patient condition changes.

    Product
    CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9) 2095801-001-0103
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-07-03

    GE CARESCAPE Canvas Smart Display monitors may fail to restart after power loss

    GE CARESCAPE Canvas Smart Display monitors may fail to turn on after a power loss, particularly following battery replacement, potentially delaying recognition of patient condition changes.

    Product
    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
    Category
    Distribution
    0 states