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

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdfRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdfRead 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