Company:Viasys Healthcare .Date of Enforcement Report 4/15/2009 Class:ll PRODUCT a) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins, Recall # Z-0998-2009; b) Viasys Healthcare ,...Read More

Company:Roche Diagnostics Corp.Date of Enforcement Report 4/15/2009 Class:ll PRODUCT a) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module; GMMI No. 04998618001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall #...Read More

Company: Medtronic, Inc.Date of Enforcement Report 4/15/2009 Class:lll PRODUCT Medtronic RV Lead Integrity Alert, Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators, Recall # Z-1172-2009 REASON Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R)...Read More

Company:Abbott Laboratories.Date of Enforcement Report 4/15/2009 Class:ll PRODUCT CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode...Read More