Company: Toshiba American Med Sys IncDate of Enforcement Report: 5/12/04 Class: III PRODUCT Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. Recall # Z-0937-04. REASON Software anomaly. The region of the...Read More

Company: Hudson Respiratory Care Inc.Date of Enforcement Report: 5/12/04 Class: II PRODUCT Concha IV Plus Heated Humidifier. Recall # Z-0929-04. REASON Software malfunction. CODE All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field. RECALLING FIRM/MANUFACTURER Hudson Respiratory Care Inc, Temecula , CA , by visit...Read More

Company: Efoora Inc. dba Virotek LLCProduct: Lancets and inoculating loops Date: 5/12/04 Your firm failed to validate computer software used as part of the quality system as required by 21 CFR 820.70(i). For example, your firm has no documented validation activities and results for the _____ electronic data management system. Your firm failed to establish...Read More