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FDA Device Recall #Z-1627-2023 — Class II — July 21, 2021

Recall Summary

Recall Number Z-1627-2023
Classification Class II — Moderate risk
Date Initiated July 21, 2021
Status Ongoing
Voluntary FDA Mandated

Recalling Firm

Firm Trophy SAS
Location Marne La Vallee Cedex 2, N/A
Product Type Devices
Quantity 895 units

Product Description

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Reason for Recall

Device failed to function as intended and/or failed to conform to their design specifications.

Distribution Pattern

Worldwide Distribution

Lot / Code Information

CS 9600

Other Recalls from Trophy SAS

Recall # Classification Product Date
Z-1095-2013 Class II CareStream Dental Kodak 2200 Intraoral X-ray sy... Sep 18, 2012
Z-0999-2013 Class II CareStream Dental CS 2100 X-ray system Produ... Sep 18, 2012
Z-1094-2013 Class II CareStream Dental Kodak 2100 Intraoral X-ray sy... Sep 18, 2012
Z-1000-2013 Class II CareStream Dental CS 2200 X-ray system Prod... Sep 18, 2012

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.