Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a perman...
FDA Device Recall #Z-0774-2014 — Class II — August 20, 2013
Recall Summary
| Recall Number | Z-0774-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 20, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Carestream Health Inc. |
| Location | Rochester, NY |
| Product Type | Devices |
| Quantity | 4 units |
Product Description
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.
Reason for Recall
Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.
Distribution Pattern
Nationwide Distribution including TX, IL, and GA.
Lot / Code Information
Serial Numbers 5049, 5073, 5133, 5162
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-1127-2014 | Class II | Model Kodak 2100 Intraoral X-Ray System, Catalo... | Jan 24, 2014 |
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.