The Recall Desk
ModerateFDA (Devices)·Z-1095-2013·Announced 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.

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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The defect is a mechanical issue (bent connector) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Trophy Sas is recalling approximately 167 CareStream Dental Kodak 2200 Intraoral X-ray systems installed in the United States. The affected units were manufactured between February 2012 and November 2012. The recall is due to a defect in the x-ray generators where a bent connector indicates poor contact of the high-tension (HT) transformer power pin.

This defect affects approximately 2% of the x-ray generators manufactured during the specified period. The systems are intended for dental radiographic examination and diagnosis of the teeth, jaw, and oral structures. The recall is classified as Class II by the FDA.

Dental practices and consumers should contact Trophy Sas for further instructions regarding the repair or replacement of the affected x-ray generators. The specific serial numbers affected are listed in the official recall documentation.

The recalled product

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.
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 →

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