Synapse CV 6. with AR. A web-based application as the primary user interface for the processin...

FDA Device Recall #Z-1172-2024 — Class II — January 3, 2024

Recall Summary

Recall Number Z-1172-2024
Classification Class II — Moderate risk
Date Initiated January 3, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm FUJIFILM Healthcare Americas Corporation
Location Lexington, MA
Product Type Devices
Quantity 8

Product Description

Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

Reason for Recall

The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.

Distribution Pattern

US domestic distribution nationwide. International distribution to Israel.

Lot / Code Information

UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0

Other Recalls from FUJIFILM Healthcare Americas Corporation

Recall # Classification Product Date
Z-1299-2026 Class II FDR Visionary Suite; Model Number: CH-200; Ve... Jan 9, 2026
Z-0044-2026 Class II FDR Visionary Suite, CH-200 Model/Version Numb... Sep 15, 2025
Z-2219-2025 Class II ASPRIRE Cristalle Mammography System (cleared u... Jun 11, 2025
Z-1407-2025 Class II Synapse PACS Software Version 7.4.x; Software V... Feb 11, 2025
Z-1884-2024 Class II Noblus AC Adapter used with the Noblus Ultrasou... Apr 11, 2024

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.