SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FDA Device Recall #Z-1748-2022 — Class II — July 12, 2022
Recall Summary
| Recall Number | Z-1748-2022 |
| 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 | 46 units |
Product Description
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
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)04580292766694(11)190926(21)V5001(250)G560045919 (01)04580292766694(11)191002(21)V5002(250)G560045719 (01)04580292766694(11)191008(21)V5004(250)G560045519 (01)04580292766694(11)191107(21)V5005(250)G560046119 (01)04580292766694(11)191113(21)V5006(250)G560048819 (01)04580292766694(11)191218(21)V5007(250)G560052019 (01)04580292766694(11)191220(21)V5008(250)G560052219 (01)04580292766694(11)200124(21)V5009(250)G560052819 (01)04580292766694(11)200124(21)V5010(250)G560052919 (01)04580292766694(11)200224(21)V5011(250)G560053419 (01)04580292766694(11)200514(21)V5017(250)G560053219 (01)04580292766694(11)200904(21)V5018(250)G1Z0169319 (01)04580292766694(11)200911(21)V5019(250)G560055619 (01)04580292766694(11)200915(21)V5020(250)G1Z0169519 (01)04580292766694(11)200925(21)V5021(250)G1Z0170519 (01)04580292766694(11)201001(21)V5022(250)G1Z0170619 (01)04580292766694(11)201009(21)V5023(250)G560059219 (01)04580292766694(11)201014(21)V5024(250)G1Z0000620 (01)04580292766694(11)201020(21)V5026(250)G560077419 (01)04580292766694(11)201020(21)V5027(250)G1Z0001220 (01)04580292766694(11)201029(21)V5028(250)G1Z0001320 (01)04580292766694(11)210108(21)V5031(250)G560001120 (01)04580292766694(11)210112(21)V5032(250)G560001220 (01)04580292766694(11)210115(21)V5033(250)G560001320 (01)04580292766694(11)210208(21)V5034(250)G560002120 (01)04580292766694(11)210216(21)V5035(250)G560002320 (01)04580292766694(11)210217(21)V5036(250)G560002420 (01)04580292766694(11)210222(21)V5037(250)G560002720 (01)04580292766694(11)210226(21)V5038(250)G560001020 (01)04580292766694(11)210410(21)V5039(250)G560003120 (01)04580292766694(11)210414(21)V5040(250)G560003220 (01)04580292766694(11)210518(21)V5041(250)G560003620 (01)04573596200544(11)210713(21)V5042(250)G560007520 (01)04573596200544(11)210713(21)V5043(250)G560003920 (01)04573596200544(11)210729(21)V5044(250)G1Z0233220 (01)04573596200544(11)210729(21)V5045(250)G1Z0245920 (01)04573596200544(11)210902(21)V5046(250)G1Z0127821 (01)04573596200544(11)210903(21)V5047(250)G1Z0127521 (01)04573596200544(11)210909(21)V5048(250)G1Z0128621 (01)04573596200544(11)210922(21)V5049(250)G1Z0128721 (01)04573596200544(11)211004(21)V5050(250)G1Z0130121 (01)04573596200544(11)220302(21)V5051(250)G1Z0208921 (01)04573596200544(11)220304(21)V5052(250)G1Z0209021 (01)04573596200544(11)220307(21)V5053(250)G1Z0214121 (01)04573596200544(11)220330(21)V5054(250)G1Z0236821 Serial Numbers: G560045919 G560045719 G560045519 G560046119 G560048819 G560052019 G560052219 G560052819 G560052919 G560053419 G560053219 G1Z0169319 G560055619 G1Z0169519 G1Z0170519 G1Z0170619 G560059219 G1Z0000620 G560077419 G1Z0001220 G1Z0001320 G560001120 G560001220 G560001320 G560002120 G560002320 G560002420 G560002720 G560001020 G560003120 G560003220 G560003620 G560007520 G560003920 G1Z0233220 G1Z0245920 G1Z0127821 G1Z0127521 G1Z0128621 G1Z0128721 G1Z0130121 G1Z0208921 G1Z0209021 G1Z0214121 G1Z0236821
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.