Surpria 64: Software Version V3.11, V3.22
- Recall Initiated
- July 12, 2022
- Recall Number
- Z-1750-2022
- Quantity
- 16 units
- Firm Location
- Lexington, MA
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
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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