Company: Sunquest Information Systems, IncDate of Enforcement Report: 2/13/2002 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0709-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 13,...Read More

Company: Sunquest Information Systems, Inc Date of Enforcement Report: 2/13/02 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0711-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.2 and 5.23. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated June 22,...Read More

Company: Sunquest Information Systems, IncDate of Enforcement Report: 2/13/02 Class: II PRODUCT FlexiLab? Laboratory Information System, Recall # B-0710-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.23 and 5.3 with RBR module. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 19, 2001....Read More

Company: ADAC LaboratoriesDate of Enforcement Report: 2/13/02 Class: II PRODUCT ADAC brand Pinnacle Radiation Therapy Planning System Radiation Therapy Treatment Software version 5.2g, Recall # Z-0524-02. REASON A Software problem that could result in incorrect radiation dosage being applied. CODE Model: 9200-0579A. RECALLING FIRM/MANUFACTURER ADAC Laboratories, Milpitas, CA, by letters on Sept. 26, 2000. Firm...Read More