| | Class 2 Device Recall Supria 64 Wholebody Xray CT System |  |
| Date Initiated by Firm | July 12, 2022 |
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| Create Date | September 16, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1750-2022 |
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| Recall Event ID |
90751 |
| 510(K)Number | K183291 |
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| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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| Product | Surpria 64: Software Version V3.11, V3.22 |
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| Code Information |
UDI:
(01)04573596200520(11)220215(21)W5086(250)G1Z0211021
(01)04580292766601(11)200130(21)W8013(250)G1Z0098019
(01)04580292766601(11)200226(21)W8014(250)G1Z0130719
(01)04580292766601(11)201217(21)W8015(250)G1Z0024020
(01)04580292766601(11)210217(21)W8016(250)G1Z0216720
(01)04580292766601(11)210528(21)W8017(250)G1Z0239620
(01)04580292766601(11)210610(21)W8018(250)G1Z0039321
(01)04580292766601(11)210628(21)W8019(250)G1Z0223420
(01)04573596200520(11)210727(21)W8020(250)G1Z0087821
(01)04573596200520(11)210825(21)W8021(250)G1Z0139021
(01)04573596200520(11)211012(21)W8022(250)G1Z0112721
(01)04573596200520(11)211026(21)W8023(250)G1Z0156921
(01)04573596200520(11)220113(21)W8024(250)G1Z0043121
(01)04573596200520(11)220113(21)W8025(250)G1Z0240221
(01)04573596200520(11)220204(21)W8026(250)G1Z0244021
(01)04573596200520(11)220204(21)W8027(250)G1Z0249821
(01)04573596200520(11)220214(21)W8028(250)G1Z0249921
Serial Numbers:
G1Z0098019
G1Z0130719
G1Z0024020
G1Z0216720
G1Z0239620
G1Z0039321
G1Z0223420
G1Z0087821
G1Z0139021
G1Z0112721
G1Z0156921
G1Z0043121
G1Z0240221
G1Z0244021
G1Z0249821
G1Z0249921
|
| FEI Number |
1000513161
|
Recalling Firm/
Manufacturer |
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
|
| For Additional Information Contact | SAME
617-861-5300 |
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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 |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 |
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| Quantity in Commerce | 16 units |
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| Distribution | US Nationwide Distribution |
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| 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
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