Day

December 26, 2018
Company: GE Healthcare, LLC Date of Enforcement Report: 12/19/2018 Class II PRODUCT Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect. Recall Number: Z-0641-2019 REASON Issue #1 affects Software Versions 6.0 SP7,...
Read More
Company: ICU Medical Inc Date of Enforcement Report: 12/17/2018 Class II PRODUCT SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient’s epidural space. Sets are intended for use with Sapphire Infusion Systems. Recall Number:...
Read More
Company: bioMerieux, Inc. Date of Enforcement Report: 12/19/2018 Class II PRODUCT VITEK 2 Systems Software Version 9.01 Update Kit. Recall Number: Z-0639-2019 REASON The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP” feature. RECALLING...
Read More
Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 12/20/18 Class II PRODUCT VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid. Recall Number: Z-0651-2019...
Read More
Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 12/20/18 Class II PRODUCT VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Recall Number:...
Read More
Company: Philips Electronics North America Corporation Date of Enforcement Report: 12/14/2018 Class II PRODUCT Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 Recall Number: Z-0614-2019 REASON There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed....
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 12/14/2018 Class II PRODUCT Dimension Vista 500, model no. 10284473 an 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 in human body fluids. Recall Number: Z-0616-2019 (Vista 500, Model...
Read More
Company: Tosoh Bioscience Inc Date of Enforcement Report: 12/14/2018 Class II PRODUCT AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the...
Read More
Company: COVIDIEN LLC Date of Enforcement Report: 12/18/2018 Class I PRODUCT Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett” 980 Pediatric Adult Ventilator Puritan Bennett” 980 Neonatal Ventilator Puritan Bennett” 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who...
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 training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.