Day

May 21, 2008
Company: Sunquest Information Systems, Inc Date of Enforcement Report 5/21/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor, version 6.0.1 and 6.0.2, Recall # B-1337-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by e-mail on March 26, 2008. Firm initiated recall is ongoing. VOLUME...
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Company: Siemens Medical Solutions, Inc., Date of Enforcement Report 5/21/2008 Class:lll PRODUCT Syngo US Workplace Picture Archiving and Communication System, software version 2.0, 94043. Material number: 10035829, Recall # Z-1138-2008 REASON Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, Inc., Mountain View,...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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