FDA Device Recall Z-1748-2022: FUJIFILM Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1748-2022.

Recall Res Number

Z-1748-2022

Recalling Firm / Manufacturer

FUJIFILM Healthcare Americas Corporation

FEI Number

1000513161

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2022-07-12

Date Posted

N/A

Date Terminated

N/A

Product Code

JAK

Event Number

90751

Product 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

Action Details FujiFilm issued Urgent Medical Device Letter were sent via email on July 12, 2022, consignees without an email contact were notified via FedEx on July 12, 2022 and July 15, 2022. Letter states reason for recall, health risk and action to take: Until your upgrade is scheduled and completed, you can continue to safely use your CT system by following these additional instructions: 1. When entering alphabetic characters in the patient information, please enter them in capital letters (e.g. ready READY ) 2. Set Auto Capital Letter to ON in the Preference Settings window. This will convert all text to capital letters for certain patient information fields. 3. Please register the following information in capital letters, as Auto Capital Letter does not apply to the following fields: a. (0008,0050) Accession Number b. (0008,0090) Referring Physician s Name c. (0010,0010) Patient s Name d. (0010,0020) Patient ID e. (0010,4000) Patient Comments f. (0032,1032) Requesting Physician g. (0032,1033) Requesting Service h. (0032,1060) Requested Procedure Description i. (0032,1070) Requested Contrast Agent j. (0040,0006) Scheduled Performing Physician s Name Please complete and return the Field Action Verification Form attached on page 5 of this communication. Responding with the information requested is essential for ensuring appropriate action is taken. Fujifilm regrets any inconvenience this action may cause and appreciates your understanding and cooperation. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at jeffrey.wan@fujifilm.com

Distribution Pattern US Nationwide Distribution

Code Information / Serial Numbers 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

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Medical Device Recall: Z-1748-2022

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer