Company: Sunquest Information Systems, Inc., Date of Enforcement Report 2/13/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor, version 6.0.1 and 6.0.2, Recall # B-0663-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by e-mail on December 14. 2007. Firm initiated recall is ongoing. VOLUME...Read More

Company: Novartis Vaccines and Diagnostic Date of Enforcement Report 2/13/2008 Class:ll PRODUCT Procleix NAT Tracker Version 3.0 Software, Stand Alone Blood, Recall # B-0662-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Novartis Vaccines and Diagnostic, Emeryville, CA, by letter on August 2, 2007 with a follow up letter on August 9,...Read More

Company: General Electric Medical Systems Information Technology Date of Enforcement Report 2/13/2008 Class:ll PRODUCT GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). (System hardware consists of a processing unit and a monitor), Recall # Z-0280-2008 REASON Two separate issues may occur with operating The CiC Pro v4.1 System...Read More