Company:Toshiba American Med Sys IncDate of Enforcement Report: 12/22/04 Class: II PRODUCT Magnetic Resonance Imaging Systems under the following names: Visart, Excelart, Excelart P2, Excelart P3, Excelart SPIN, Excelart VANTAGE. Recall # Z-0270-05. REASON Software defect causes images to be rotated 180 degrees. CODE All serial numbers. RECALLING FIRM/MANUFACTURER Toshiba American Med Sys Inc., Tustin,...Read More

Company: Toshiba American Med Sys IncDate of Enforcement Report: 12/22/04 Class: II PRODUCT Magnetic Resonance Imaging Systems, under the following names: Visart Excelart P2 Excelart P3 Excelart SPIN. Recall # Z-0273-05. REASON Software defect causes patient identification number to be truncated. CODE No specific codes were listed. RECALLING FIRM/MANUFACTURER Toshiba American Med Sys Inc, Tustin,...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 12/22/04 Class: II PRODUCT MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-0297-05. REASON Test results may be adversely affected by software shutting down the cooling blocks in systems with software versions 3.09. CODE All systems using software version 3.09. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp.,...Read More

Company:Cyberonics Inc.Product: Vagus Nerve Stimulator Date: 12/22/04 During an inspection of your firm’s manufacturing operations located in Houston, Texas, on July 12 through September 15, 2004, United States Food and Drug Administration (FDA) Investigator, Ellen J. Tave, determined that your firm manufactures the Vagus Nerve Stimulator (VNS), an implanted generator that is indicated for use...Read More

Company: Coherent, InccDate of Enforcement Report: 12/22/04 Class: II PRODUCT Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. Recall # Z-0360-05. REASON Software problem that may cause unintended emission of laser radiation. CODE All serial numbers are affected by this recall action. Serial numbers range from 1003 to 1092....Read More