Company: Medical Information Technology, Inc.Date of Enforcement Report 10/5/11 Class ll: PRODUCT 1) MEDITECH Blood Bank Software MAGIC 5.63 and 5.64. Recall # B-2169-11; 2) MEDITECH Blood Bank Software Client Server 5.65, 6.05 and 6.06. Recall # B-2170-11 REASON Software, with a glitch or defect which could lead to an incompatible unit being transfused, was...Read More

Company: Medical Information Technology, Inc.Date of Enforcement Report 10/5/11 Class ll: PRODUCT 1) MEDITECH Blood Bank Software MAGIC 5.6 Release. Recall # B-2167-11; 2) MEDITECH Blood Bank Software Client Server 5.6, 6.0 and 6.1. Recall # B-2168-11 REASON Software, with a glitch or defect which could lead to an incompatible unit being transfused, was distributed....Read More

Company: Medical Information Technology, Inc.Date of Enforcement Report 10/5/11 Class ll: PRODUCT MEDITECH Blood Bank Software Client Server 6.0 and 6.1. Recall # B-2171-11 REASON Software, with a glitch or defect was distributed. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood, MA, by e-mailed task updates on February 11, 2011. Firm initiated recall is complete. VOLUME...Read More

Company: One Lambda, Inc.Date of Enforcement Report 10/5/11 Class ll: PRODUCT HLA Fusion Software Version, Product Number: FUSPGR, version 2.0.0-SP1, RSSOH1AC-Update.exe, Product: RSSOH1A. Recall # 2166-11 REASON HLA Fusion Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER One Lambda, Inc., Canoga Park, CA, by letter on January 17, 2011. Firm initiated recall is...Read More

Company: Boston Scientific CRM Corp. Date of Enforcement Report 10/5/11 Class ll: PRODUCT Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Boston Scientific, LATITUDE RF Communicator & Software, Model 6482. LATITUDE Communicator REF 6468 (only distributed outside the US) The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible...Read More

Company: GE Healthcare, LLCDate of Enforcement Report 10/5/11 Class ll: PRODUCT ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets. Recall # Z-3282-2011 REASON GE Healthcare has become aware that image orientation of reference series displayed in...Read More