The Recall Desk

FDA (Devices) recall action 86932

GE Healthcare, LLC recalled 2 products on 2020-12-30

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
2020-12-30
Critical
0
Units
5

Why these products were recalled

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

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

1–2 of 2

  • HighFDA (Devices)··2020-12-30

    GE Healthcare Recalls Three Revolution CT Systems for Protocoling Errors

    GE Healthcare is recalling three Revolution CT systems due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.

    Product
    Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2020-12-30

    GE Healthcare Recalls Two Revolution CT ES Units for Protocoling Error

    GE Healthcare is recalling two Revolution CT ES units due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.

    Product
    Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Distribution
    3 states