Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, I...
FDA Device Recall #Z-1127-2014 — Class II — January 24, 2014
Recall Summary
| Recall Number | Z-1127-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 24, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Carestream Health Inc. |
| Location | Rochester, NY |
| Product Type | Devices |
| Quantity | Domestic: 347 units (total for both) |
Product Description
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.
Reason for Recall
Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
Distribution Pattern
Worldwide distribution. USA (nationwide) and the country of Canada.
Lot / Code Information
Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD
Other Recalls from Carestream Health Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2143-2014 | Class III | Ultra-speed Dental Film, Catalog Number/REF 834... | Jul 2, 2014 |
| Z-2142-2014 | Class III | INSIGHT Dental Film, Catalog Number/REF 811 078... | Jul 2, 2014 |
| Z-2137-2014 | Class II | KODAK DirectView DR 9000 System, Catalog Numbe... | May 30, 2014 |
| Z-1128-2014 | Class II | Model Kodak 2200 Intraoral X-Ray System, Catalo... | Jan 24, 2014 |
| Z-0229-2014 | Class II | Carestream Vue PACS; UNLIMITED READING LIC ADD ... | Sep 16, 2013 |
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.