11 results
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69ms
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Sources: EU EUDAMED, US FDA
SOFTMIC(GUI)
FDA Adverse Event
Malfunction
·SOFT COMPUTER CONSULTANTS, INC.·Product code LNX·September 17, 2007
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code NSX·May 31, 2017
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.
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code NSX·October 6, 2016
SoftCytogenetics
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code JQP·March 31, 2021
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.
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code NSX·October 6, 2016
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.
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code JQP·March 31, 2021
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·August 9, 2017
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.
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·February 1, 2017
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.
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·February 1, 2017
SoftCytogenetics
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·July 28, 2021
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.
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·July 28, 2021