Recall archive / FDA device enforcement
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C — FDA record Z-1748-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 12, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
- Reason
- 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
- Classification
- Class II
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 46 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1748-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide Distribution
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 21, 2022
- Recall initiation date
- Jul 12, 2022
- Center classification date
- Sep 15, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.