FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communic...
FDA Device Recall #Z-1611-2015 — Class II — February 4, 2015
Recall Summary
| Recall Number | Z-1611-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 4, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Fujifilm Medical Systems U.S.A., Inc. |
| Location | Stamford, CT |
| Product Type | Devices |
| Quantity | 30 units |
Product Description
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Reason for Recall
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Distribution Pattern
Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada
Lot / Code Information
Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Other Recalls from Fujifilm Medical Systems U.S.A., Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1775-2021 | Class II | Synapse Cardiovascular (Synapse CV). Software... | Apr 30, 2021 |
| Z-1348-2021 | Class II | Synapse PACS - Radiological Image Processing Sy... | Mar 2, 2021 |
| Z-1412-2021 | Class II | ¿TASWako Chip Cassette is part of the Wako ¿TAS... | Feb 18, 2021 |
| Z-0932-2021 | Class III | Wako HDL-C/LDL-C Calibrator - Product Usage: de... | Dec 22, 2020 |
| Z-0918-2021 | Class II | FUJIFILM Synapse PACS Software: versions 7.0.0 ... | Dec 11, 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.