Company:Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 9/4/2013 Class ll: PRODUCT Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes...Read More
Company: Nidek Inc. Date of Enforcement Report: 9/4/2013 Class ll: PRODUCT NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. Recall Number Z-2046-2013 REASON Under certain circumstances, the Left eye image may be saved as the Right eye...Read More
Company: MCKESSON TECHNOLOGIES INC. Date of Enforcement Report: 9/4/2013 Class ll: PRODUCT Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures. Recall Number Z-2089-2013 REASON The firm issued a clinical alert after users reported an...Read More
Jabones Pardo S.A..Product: pharmaceutical manufacturing facility Date: 8/22/2013 an investigator from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of Section...Read More
Company: GE Healthcare, LLC Date of Enforcement Report:9/4/2013 Class ll: PRODUCT GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports...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.