Company:Roche Molecular Systems, IncDate of Enforcement Report:10/3/2007 Class:ll PRODUCT Ampilink Software versions 1.1, 1.3, 1.4, 2.41 and 2.42 [COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor v1.5 test; COBAS Amplicor HIV-1 Monitor test v1.5; COBAS AmpliScreen HBV Test; COBAS AmpliScreen HCV Test, version 2; COBAS AmpliScreen HIV-1 Test, version 1.5], Recall # B-1554-07 REASON For select COBAS AMPLICOR...Read More

Company:Philips Nuclear Medicine, Inc., Date of Enforcement Report:10/3/2007 Class:ll PRODUCT The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating...Read More

Company:Misys Encompass Versions 2.2.1, 2.3 and 2.4sDate of Enforcement Report:10/3/2007 Class:ll PRODUCT Misys Encompass Versions 2.2.1, 2.3 and 2.4, Recall # B-1557-07 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, by e-mail on April 16, 2007. Firm initiated recall is ongoing.. VOLUME OF...Read More

Company:Intuitive Surgical, Inc., Date of Enforcement Report:10/3/2007 Class:ll PRODUCT Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Recall # Z-1244-2007 REASON Under certain circumstances, the product’s software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual...Read More

Company:Cerner Corp.Date of Enforcement Report:10/3/2007 Class:ll PRODUCT Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities Recall # Z-1243-2007 REASON Defects in the Auto Launch functionality make it possible for a mismatch of patient data. RECALLING FIRM/MANUFACTURER Cerner Corp., Kansas City, MO, by telephone on August 23, 2007 and by letters dated...Read More

Company:Baxa Corporation, IncDate of Enforcement Report:10/3/2007 Class:l PRODUCT Exacta-Mix 2400 OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Recall # Z-1238-2007 REASON A software defect could allow up to 50mL of extra volume being added to a TPN (Total Parenteral Nutrition) solution. RECALLING FIRM/MANUFACTURER Baxa Corporation, Englewood, CO, by telephone and letter on June 27,...Read More