Company: Iba Dosimetry Gmbh. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological. Recall Number Z-0168-2015 REASON Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over...Read More
Company: Smiths Medical ASD, Inc. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump,...Read More
Company: Beckman Coulter Inc.. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.