Soft Computer Consultants

5 recalls •

🏥 Medical Devices

• Categories: Diagnostic Equipment, Other Medical Devices

SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.

Class I - Dangerous

Software showing wrong results reported, PDF not match HIS.

Mar 31, 2021 Diagnostic Equipment View Details →

SoftCytogenetics

Class I - Dangerous

Software is given wrong results going out to HIS on test that had reruns.

Mar 31, 2021 Other Medical Devices Nationwide View Details →

SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

Class I - Dangerous

Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.

May 31, 2017 Other Medical Devices View Details →

SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.

Class I - Dangerous

Software error. Potential for incorrect results

Oct 6, 2016 Diagnostic Equipment Nationwide View Details →

Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.

Class I - Dangerous

Software error. Potential for incorrect results

Oct 6, 2016 Diagnostic Equipment Nationwide View Details →