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FUJIFILM Healthcare Americas Corporation recalls Surpria 64: Software Version V3.11, V3.22
Recalled September 21, 2022 · FDA recall Z-1750-2022 · FUJIFILM Healthcare Americas
Hazard
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 · FDA Class II
Units
16 units
Sold at
US Nationwide Distribution
Description
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
Product
Surpria 64: Software Version V3.11, V3.22
Manufacturer(s)
FUJIFILM Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →