Company:SCC Soft ComputerDate of Enforcement Report: 2/11/2015 Class lI: PRODUCT SoftLab with SA HIS versions 22.214.171.124-126.96.36.199 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory. Recall Number Z-1038-2015 REASON The interface fails to send abnormal flags for Reference Lab test results. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL...Read More
Company:Radiometer America IncDate of Enforcement Report: 2/11/2015 Class lI: PRODUCT ABL90 FLEX analyzer, Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. Recall Number Z-1046-2015 REASON The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This...Read More
Company: Covidien LP (formerly Nellcor Puritan Bennett Inc.) Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of...Read More
Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment. Recall Number Z-1047-2015 REASON Potential for misinterpretation of...Read More
Company: Carl Zeiss Meditec AG Date of Enforcement Report 2/11/2015 Class lI: PRODUCT FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928...Read More
Company: Annimas Corp. Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. Recall Number Z-1034-2015 REASON ICalibration factors in the pump overwritten during a programming step. The force sensor...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 firstname.lastname@example.org for more info.