The Recall Desk
HighFDA (Devices)·Z-1000-2013·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'High' severity score under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Trophy Sas is recalling the CareStream Dental CS 2200 X-ray system. The intended use of these products is for dental radiographic examination and diagnosis of the teeth, jaw, and oral structures. Approximately 167 units are installed in the United States, with nationwide distribution.

The recall is due to a defect in approximately 2% of the x-ray generators manufactured between February 2012 and November 2012. These units were returned due to a bent connector associated with the generator, which indicates poor contact of the HT transformer power pin. This defect is classified as FDA Class II.

Dental practices and consumers with these specific units should contact Trophy Sas for further instructions on how to address the defect.

The recalled product

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.
Manufacturer
Trophy Sas
Category
Medical Device — Dental X-ray System
Hazard
Affected units
167

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Trophy Sas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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