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.
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 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
- 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
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