FDA-Device2022-09-21Class II
Surpria 64: Software Version V3.11, V3.22
FUJIFILM Healthcare Americas Corporation
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
Sold states
US Nationwide Distribution
Affected count
16 units
Manufactured in
81 Hartwell Ave Ste 300, Lexington, MA, United States
Products
Surpria 64: Software Version V3.11, V3.22
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1750-2022Don't want to check this manually?
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