SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Check against the official notice below — it lists the full affected range.
FUJIFILM Healthcare Americas Corporation is recalling SCENARIA View software versions V1.08, V1.09B, V1.09C, V1.09D, V1.0B, and V1.0C due to a technical error that affects 46 units distributed nationwide. During scanning operations, Error 00003050 or 00003052 may occur, preventing captured images from being reconstructed and preventing raw data from displaying in the work list.
This malfunction requires patients to undergo additional scanning to properly capture images for reconstruction, thereby exposing them to additional radiation. The affected units are identified by specific lot and code numbers distributed between September 2019 and February 2021. The recall notice does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: US Nationwide Distribution Quantity: 46 units Lot/code info: 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)04580292
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.