Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system dev...
FDA Device Recall #Z-2060-2018 — Class II — January 12, 2018
Recall Summary
| Recall Number | Z-2060-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 12, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Shimadzu Medical Systems |
| Location | Torrance, CA |
| Product Type | Devices |
| Quantity | 17 |
Product Description
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.
Reason for Recall
When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
Distribution Pattern
US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
Lot / Code Information
Serial #: 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFC2A001, 3M72BFC2C001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003,3M72BFC33001, 3M72BFC34001, 3M72BFB35005, 3M72BFC37002, 3M72BFC42001, 3M72BFB46002
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.