Recall Z-0999-2013— Trophy Sas
Class II · Terminated
Class II FDA medical device recall by Trophy Sas, initiated 2012-09-18, terminated 2017-05-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Trophy Sas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-18
- Terminated
- 2017-05-02
- Firm location
- Croissy Beaubourg, France
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.