Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with...
FDA Device Recall #Z-1175-2016 — Class II — January 14, 2016
Recall Summary
| Recall Number | Z-1175-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 14, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Toshiba American Medical Systems Inc |
| Location | Tustin, CA |
| Product Type | Devices |
| Quantity | 28 |
Product Description
Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
Reason for Recall
When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the "OK" button to re-acquire the image data or to select the¿'Cancel" button to cancel the re-acquisition. As instructed the user selected "OK" and the same message window appeared. This same operation was repeated several times with the identical result - no image. Finally, the user selected "Cancel" and the re-acquisition was terminated.
Distribution Pattern
Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
Lot / Code Information
Serial number : USB1522023
Other Recalls from Toshiba American Medical Systems Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2315-2018 | Class II | Diagnostic Ultrasound System, Aplio I-series. ... | Jan 4, 2018 |
| Z-0843-2018 | Class II | INFX-8000C Fluoroscopic X-Ray Systems | Dec 29, 2017 |
| Z-0842-2018 | Class II | INFX-8000F Fluoroscopic X-Ray Systems | Dec 29, 2017 |
| Z-0845-2018 | Class II | INFX-8000H Fluoroscopic X-Ray Systems | Dec 29, 2017 |
| Z-0844-2018 | Class II | INFX-8000V Fluoroscopic X-Ray Systems; INFINIX ... | Dec 29, 2017 |
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.