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Surpria: Software Version V3.11, V3.22

FDA Device Recall #Z-1749-2022 — Class II — July 12, 2022

Recall Summary

Recall Number Z-1749-2022
Classification Class II — Moderate risk
Date Initiated July 12, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm FUJIFILM Healthcare Americas Corporation
Location Lexington, MA
Product Type Devices
Quantity 20 units

Product Description

Surpria: Software Version V3.11, V3.22

Reason for Recall

Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

UDI: (01)04580292766601(11)200130(21)W5067(250)G560045319 (01)04580292766601(11)200220(21)W5068(250)G560048119 (01)04580292766601(11)200902(21)W5069(250)G560071519 (01)04580292766601(11)201210(21)W5070(250)G560075519 (01)04580292766601(11)201225(21)W5071(250)G1Z0040620 (01)04580292766601(11)210218(21)W5072(250)G1Z0063520 (01)04580292766601(11)210512(21)W5073(250)G1Z0244920 (01)04580292766601(11)210519(21)W5074(250)G1Z0048121 (01)04573596200520(11)210818(21)W5075(250)G1Z0083221 (01)04573596200520(11)210903(21)W5076(250)G1Z0094621 (01)04573596200520(11)210903(21)W5077(250)G1Z0094521 (01)04573596200520(11)210903(21)W5077(250)G1Z0094521 (01)04573596200520(11)211018(21)W5079(250)G1Z0123621 (01)04573596200520(11)211115(21)W5080(250)G1Z0190221 (01)04573596200520(11)211122(21)W5081(250)G1Z0190021 (01)04573596200520(11)211122(21)W5082(250)G1Z0190121 (01)04573596200520(11)211227(21)W5083(250)G1Z0190321 (01)04573596200520(11)211228(21)W5084(250)G1Z0210821 (01)04573596200520(11)220209(21)W5085(250)G1Z0210921 (01)04573596200520(11)220215(21)W5086(250)G1Z0211021 Serial Numbers: G560045319 G560048119 G560071519 G560075519 G1Z0040620 G1Z0063520 G1Z0244920 G1Z0048121 G1Z0083221 G1Z0094621 G1Z0094521 G1Z0115321 G1Z0123621 G1Z0190221 G1Z0190021 G1Z0190121 G1Z0190321 G1Z0210821 G1Z0210921 G1Z0211021

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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
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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.

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