MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
FDA Device Recall #Z-0867-2022 — Class II — January 10, 2022
Recall Summary
| Recall Number | Z-0867-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 10, 2022 |
| Status | Ongoing |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | Shimadzu Medical Systems |
| Location | Torrance, CA |
| Product Type | Devices |
| Quantity | 25 systems |
Product Description
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Reason for Recall
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
Distribution Pattern
U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A
Lot / Code Information
Model: FLUOROspeed X1 Generator Number: D150-40 Serial Numbers: MQ493E19C001 MQ493E3B8002 MQ493E3B9001 MQ493E1B4001 MQ493E1A1003 MQ493E1A3001 MQ493E1B5001 MQ493E3B8001 MQ493E1A5001 MQ493E1A1005 MQ493E1A2001 MQ493E1A4001 MQ493E1B6002 MQ493E1A8001 MQ493E1B4002 MQ493E1A4003 MQ493E1A4002 MQ493E1B6001 MQ493E1A2002 MQ493E1AC001 MQ493E1A1002 MQ493E19C002 MQ493E1A3003 MQ493E1A1004 MQ493E1A3002
Other Recalls from Shimadzu Medical Systems
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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-0655-2022 | Class II | Digital Angiography System Shimadzu Trinias ... | Dec 16, 2021 |
| Z-0654-2022 | Class II | Digital Angiography System Bransist safire G... | Dec 16, 2021 |
| Z-0554-2021 | Class II | Bransist Safire, Digital Angiography System con... | Nov 18, 2020 |
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.