The Recall Desk
ModerateFDA (Devices)·Z-0999-2013·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The defect involves a mechanical component (bent connector) causing poor electrical contact, which is a functional defect rather than a direct, immediate physical hazard like fire or shock, and no injuries are reported.

Plain-English summary

Trophy Sas is recalling approximately 167 CareStream Dental CS 2100 X-ray systems installed in the United States. These systems are used for dental radiographic examination and diagnosis of the teeth, jaw, and oral structures.

The recall is due to a defect in the x-ray generators manufactured between February 2012 and November 2012. Approximately 2% of these generators were returned due to a bent connector associated with the generator, which indicates poor contact of the high-tension (HT) transformer power pin.

Dental practices with affected units should contact Trophy Sas for further instructions on the recall.

The recalled product

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.
Manufacturer
Trophy Sas
Category
Medical Device — Dental Imaging
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 →

Related recalls

Same manufacturer · Trophy Sas

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Same hazard · electrical defect

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