Surpria 64: Software Version V3.11, V3.22
Check against the official notice below — it lists the full affected range.
FUJIFILM Healthcare Americas Corporation is recalling 16 units of Surpria 64 imaging equipment running software versions V3.11 or V3.22. The equipment may experience errors 00003050 or 00003052 during scanning, which prevents captured images from being reconstructed and raw data from displaying in the work list. This malfunction could require patients to undergo additional scanning to properly capture images for reconstruction, resulting in increased radiation exposure.
The recall affects equipment distributed nationwide in the United States. Affected consumers can identify recalled units by checking their serial numbers or UDI codes against the lot information provided in the recall notice. The source does not specify what remedy affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Quantity: 16 units 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.