Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The cathet...
FDA Device Recall #Z-0360-2020 — Class II — February 8, 2019
Recall Summary
| Recall Number | Z-0360-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 8, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Canon Medical System, USA, INC. |
| Location | Tustin, CA |
| Product Type | Devices |
| Quantity | 9 systems |
Product Description
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
Reason for Recall
Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.
Lot / Code Information
Model CAT-870B D053991 Serial No. Manufacture Date 99D08X2101 October 2008 99D0582039 August 2005 99D0762072 June 2007 99D0852090 May 2008 99D07Y2078 November 2007 99D0812081 January 2008 99D0582042 August 2005 99D0552033 May 2005 D551206 May 2005
Other Recalls from Canon Medical System, USA, INC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1018-2026 | Class II | VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 | Dec 19, 2025 |
| Z-1178-2026 | Class II | Alphenix INFX-8000H, interventional fluoroscopi... | Dec 19, 2025 |
| Z-1017-2026 | Class II | VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 | Dec 19, 2025 |
| Z-1177-2026 | Class II | Alphenix INFX-8000F, interventional fluoroscopi... | Dec 19, 2025 |
| Z-1179-2026 | Class II | Alphenix INFX-8000V, interventional fluoroscopi... | Dec 19, 2025 |
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.