Company:Terumo Advanced Perfusion System 1 Date of Enforcement Report:2/7/2007 Class:ll PRODUCT Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046, Recall # Z-0381-2007 REASON Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and...Read More

Company:GE Healthcare Integrated IT Solution Date of Enforcement Report:1/31/2007 Class:ll PRODUCT GE Centricity PACS RA 1000 Workstation; for diagnostic image analysis; Software versions 2.1.XX. and 3.0.XX. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential, Recall # Z-0373-2007 REASON The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display...Read More

Company:Cyberonics, Incl Date of Enforcement Report:1/31/2007 Class:ll PRODUCT a) Cyberonics VNS Therapy System, Model 250-‘HAND HELD’ programming software v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0341-2007; b) Handhelds-Cyberonics VNS Therapy System, Model 2500-‘Handhelds’ preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0342-2007 REASON During programming, pulse generator may be inadvertently set to...Read More