CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage:… — Class II medical device recall Z-1094-2013
Terminated recall by Trophy Sas, reported 2013-05-08, distributed nationwide. There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012
| Recall number | Z-1094-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trophy Sas, Croissy Beaubourg, France |
| Recall initiated | 2012-09-18 |
| Classified | 2013-05-02 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2017-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 167 installed |
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.
Reason for recall
There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1094-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.