Company:Symbios Medical Products.Date of Enforcement Report 6/12/2013 Class I: PRODUCT Part 510031 Disposable Single Infusion Pump, quantity Includes… TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO… found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 – BP, w/ Epidural...Read More
Company: American Optisurgical.Date of Enforcement Report: 6/12/2013 ClassL Ill: PRODUCT Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. Recall Number Z-1441-2013 REASON Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different...Read More
Company: American Optisurgical. Date of Enforcement Report: 6/12/2013 Class ll: PRODUCT American Optisurgical’s TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. Recall Number Z-1516-2013 REASON The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board....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.