Company:Volcano Corporation Date of Enforcement Report 9/19/12 Class ll: PRODUCT Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology. Recall Number Z-2345-2012 REASON The display on the...Read More
Company:Sunquest Information Systems, Inc. Date of Enforcement Report 9/19/12 Class ll: PRODUCT Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow...Read More
Company:Micro Typing Systems Inc. Date of Enforcement Report 9/19/12 Class ll: PRODUCT ORTHO-ProVue (TM) A modular, microprocessor-controled instrument.B-2373-12 REASON ORTHO ProVue, with a software glitch or defect that could lead to erroneuous results, was distributed. RECALLING FIRM/MANUFACTURER Capintec Inc., Pompano Beach FL on 7/8/2004. Voluntary: Firm Initiated recall has been terminated. VOLUME OF PRODUCT IN...Read More
Company:GE Healthcare, LLC. Date of Enforcement Report 9/19/12 Class ll: PRODUCT GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures....Read More
Company:GE Healthcare LLC Date of Enforcement Report 9/19/12 Class ll: PRODUCT Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. Recall Number Z-2255-2012 REASON Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is...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.