Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
FDA Device Recall #Z-0917-2017 — Class II — November 20, 2016
Recall Summary
| Recall Number | Z-0917-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 20, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Shimadzu Medical Systems |
| Location | Torrance, CA |
| Product Type | Devices |
| Quantity | 39 units |
Product Description
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
Reason for Recall
Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.
Distribution Pattern
US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA
Lot / Code Information
Serial No. 41C351641002 41C351643001 41C351641003 41C351641001 41C351646001 41C351646002 41C351647001 41C35164A001 41C35164B001 41C35164C001 41C351651001 41C351651002 41C351653003 41C351653002 41C351653004 41C351653005 41C351654002 41C351655001 41C351655002 41C351655003 41C351656001 41C351659001 41C35165A001 41C35165A002 41C35165A003 41C35165B001 41C35165B002 41C351661001 41C351661002 41C351662001 41C351663001 41C351663002 41C351664001 41C351664002 41C351664004 41C351664005 41C351665001 41C351665003 41C351665002
Other Recalls from Shimadzu Medical Systems
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0867-2022 | Class II | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 | Jan 10, 2022 |
| Z-0869-2022 | Class II | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 | Jan 10, 2022 |
| Z-0868-2022 | Class II | MODEL: X-RAY TV SYSTEM SONIALVISION G4 | Jan 10, 2022 |
| Z-0654-2022 | Class II | Digital Angiography System Bransist safire G... | Dec 16, 2021 |
| Z-0655-2022 | Class II | Digital Angiography System Shimadzu Trinias ... | Dec 16, 2021 |
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.