SCC Soft Computer

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1065-2015Class IISoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.November 26, 2014
Z-1038-2015Class IISoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be useMay 20, 2014
Z-1573-2014Class IISCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory inforJanuary 29, 2014
Z-2143-2012Class IISoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13.October 17, 2011