Company: SCC Soft ComputerDate of Enforcement Report 11/24/2010 Class ll: PRODUCT SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. Recall # Z-0088-2011 REASON Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a...Read More

Company: Impac Medical Systems, Inc. Date of Enforcement Report 11/24/2010 Class ll: PRODUCT Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class 11b. Recall # Z- 0076-2011 REASON Software issue; matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different...Read More