The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1094-2013·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 bent connector and poor power contact, which is a functional failure rather than a direct, immediate physical hazard like a fire or shock, and no injuries are reported.

Plain-English summary

Trophy Sas is recalling the CareStream Dental Kodak 2100 Intraoral X-ray system. The recall affects approximately 167 units installed in the United States. The intended use of these products is 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 errors. The specific defect is a bent connector associated with the generator, which indicates poor contact of the HT transformer power pin.

The recall is distributed nationwide in the USA. Consumers and dental professionals should check their equipment against the specific serial codes listed in the official recall notice to determine if their unit is affected.

The recalled product

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.
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

See all →

Same hazard · electrical defect

See all →

Similar recalls