Z-1750-2022 Class II Ongoing
FDA device recall Z-1750-2022 was initiated by FUJIFILM Healthcare Americas Corporation on Jul 12, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 16 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 21, 2022
- Initiation Date
- Jul 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
Surpria 64: Software Version V3.11, V3.22
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 Pattern
US Nationwide Distribution
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1750-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026