Drug recall
CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these…
FDA recall event 64589 · Class II · Trophy Sas
Key facts
| Event ID | 64589 |
|---|---|
| Recall numbers | Z-0999-2013, Z-1000-2013, Z-1094-2013, Z-1095-2013 |
| Recalling firm | Trophy Sas |
| Product type | Devices |
| Products | 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…, CareStream Dental CS 2200 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…, 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 18, 2012 |
| Report date | May 8, 2013 |
| Termination date | May 2, 2017 |
| City | Croissy Beaubourg |
| Country | France |
| FEI number | 3000095401 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: