The Recall Desk

FDA (Devices) recall action 64589

Trophy Sas recalled 4 products on 2013-05-08

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2013-05-08
Critical
0
Units
668

Why these products were recalled

There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

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.

1–4 of 4

  • HighFDA (Devices)··2013-05-08

    Trophy CareStream Dental CS 2200 X-ray System Recall for Bent Connector

    Trophy Sas is recalling CareStream Dental CS 2200 X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-08

    Trophy CareStream Dental X-ray System Recalled for Bent Connector Defect

    Trophy Sas is recalling CareStream Dental Kodak 2100 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-08

    Trophy CareStream Dental Kodak 2200 Intraoral X-ray System Recall

    Trophy Sas is recalling CareStream Dental Kodak 2200 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-08

    Trophy CareStream Dental CS 2100 X-ray System Recalled for Defective Connector

    Trophy Sas is recalling CareStream Dental CS 2100 X-ray systems due to a bent connector causing poor contact in the high-tension transformer power pin.

    Product
    CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Distribution
    0 states