The Recall Desk

FDA (Devices) recall action 68528

GE Healthcare, LLC recalled 2 products on 2014-07-09

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
2014-07-09
Critical
0
Units
4,513

Why these products were recalled

GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.

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

  • SevereFDA (Devices)··2014-07-09

    GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Collimator Fall Risk

    GE Healthcare is recalling Proteus XR/a and Revolution XR/d X-ray systems due to a collimator installation error that caused a serious patient injury.

    Product
    GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-07-09

    GE Healthcare Recalls Revolution XR/d X-ray Systems Due to Collimator Fall Risk

    GE Healthcare is recalling Revolution XR/d digital radiographic systems because a collimator installation error during maintenance could cause the device to fall and injure patients.

    Product
    GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose dia
    Category
    Distribution
    2 states