FUJIFILM Healthcare Americas Corporation Recall 90751
Description: Surpria 64: Software Version V3.11, V3.22
FUJIFILM Healthcare Americas Corporation Recall 90751 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1750-2022 |
| Event ID | 90751 |
| Event Description | Surpria 64: Software Version V3.11, V3.22 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 16 units |
| Recall Reason | 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 |
| Device Classification | 20220921 |
| Device 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 |
| Center Classification Date | 20220915 |
| Recall Initiation Date | 20220712 |
| Recalling Firm | FUJIFILM Healthcare Americas Corporation |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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