| |
Class 2 Device Recall SCENARIA View |
 |
| Date Initiated by Firm |
July 12, 2022 |
| Create Date |
September 16, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1748-2022 |
| Recall Event ID |
90751 |
| 510(K)Number |
K213829
|
| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product |
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
|
| 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
|
Recalling Firm/
Manufacturer |
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
|
| For Additional Information Contact |
SAME
617-861-5300
|
Manufacturer 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
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
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 |
| Quantity in Commerce |
46 units |
| Distribution |
US Nationwide Distribution |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = FUJIFILM Healthcare Corporation
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