CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for ...
FDA Device Recall #Z-1000-2013 — Class II — September 18, 2012
Recall Summary
| Recall Number | Z-1000-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 18, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Trophy Sas |
| Location | Croissy Beaubourg |
| Product Type | Devices |
| Quantity | 167 installed in the US |
Product Description
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 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.
Distribution Pattern
USA Nationwide Distribution
Lot / Code Information
ABYJ011 ABYJ012 ABYJ020 through ABYJ026 ACJY522 ACYJ004 through ACYJ007 ACYJ009 through ACYJ012 ACYJ014 ACYJ015 ACYJ017 through ACYJ023 ACYJ500 through ACYJ509 ACYJ517 through ACYJ521 ACYJ523 through ACYJ531 ACYJ533 through ACYJ536 ADYJ001 through ADYJ005 ADYJ007 ADYJ008 ADYJ011 through ADYJ013 ADYJ015 through ADYJ018 ADYJ020 through ADYJ032 ADYJ034 through ADYJ037 ADYJ039 through ADYJ049 ADYJ051 ADYJ054 ADYJ056 ADYJ061 ADYJ062 ADYJ064 through ADYJ067 ADYJ069 through ADYJ073 ADYJ075 through ADYJ082 AEYJ001 through AEYJ003 AEYJ005 AEYJ006 AEYJ008 through AEYJ010 AEYP003 through AEYP011 AEYP024 through AEYP026 AEYP028 through AEYP030 AFYP005 through AFYP008 AFYP012 AFYP014 through AFYP018 AFYP021 AFYP022 AGYP010 AGYP012 AGYP016 AGYP018 through AGYP020 AGYP022 AGYP025 AGYP027 AGYP028 AGYP030 AGYP031 AGYP033 through AGYP041 AGYP045 AGYP046 AGYP068 AGYP069 AGYP073 AGYP086 AGYP088 AGYP089 AGYP092 AJYP025 AJYP027 AKYP001 AKYP007 AKYP009
Other Recalls from Trophy Sas
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1627-2023 | Class II | CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿prod... | Jul 21, 2021 |
| Z-1095-2013 | Class II | CareStream Dental Kodak 2200 Intraoral X-ray sy... | Sep 18, 2012 |
| Z-0999-2013 | Class II | CareStream Dental CS 2100 X-ray system Produ... | Sep 18, 2012 |
| Z-1094-2013 | Class II | CareStream Dental Kodak 2100 Intraoral X-ray sy... | Sep 18, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.