SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking ...
FDA Device Recall #Z-2655-2017 — Class II — May 23, 2017
Recall Summary
| Recall Number | Z-2655-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 23, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Shimadzu Medical Systems Usa Com |
| Location | Torrance, CA |
| Product Type | Devices |
| Quantity | 1673 units total |
Product Description
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
Reason for Recall
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Distribution Pattern
Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan
Lot / Code Information
Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001
Other Recalls from Shimadzu Medical Systems Usa Com
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0959-2019 | Class II | BRANSIST safire Product Usage: DIGITAL ANGI... | Jan 14, 2019 |
| Z-0864-2019 | Class II | TRINIAS for diagnostic imaging and intervention... | Jan 14, 2019 |
| Z-1039-2019 | Class II | SHIMADZU MobileDaRt Evolution (MX8 Version), Mo... | Jan 14, 2019 |
| Z-0197-2019 | Class II | TRINIAS Digital Angiographic System intended to... | Jun 15, 2018 |
| Z-2654-2017 | Class II | SHIMADZU RADspeed Pro Catalog Number: RADspeed ... | May 23, 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.