The Recall Desk

FDA (Devices) recall action 84438

GE Healthcare, LLC recalled 2 products on 2020-01-29

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
2020-01-29
Critical
0
Units
3,599

Why these products were recalled

GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

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)··2020-01-29

    GE Healthcare Recalls Carestation Anesthesia Systems Due to Loose Cable Risk

    GE Healthcare is recalling 280 Carestation anesthesia systems worldwide due to a potential loose cable connection that could cause a loss of mechanical ventilation.

    Product
    Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-01-29

    GE Healthcare Recalls Carestation Anesthesia Systems Due to Loose Cable Connection

    GE Healthcare is recalling 3,319 Carestation anesthesia systems worldwide due to a potential loose cable connection that could cause loss of mechanical ventilation.

    Product
    Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
    Category
    Distribution
    0 states