Day

September 2, 2015
Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report: 8/26/2015 Class lI: PRODUCT RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy. Recall Number Z-2457-2015 REASON Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used....
Read More
Company: Philips Electronics North America Corporation Date of Enforcement Report 9/2/2015 Class lI: PRODUCT Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians. Recall Number Z-2383-2015 REASON The system is designed to emit a...
Read More
Company:Nidek Inc.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement...
Read More
Company:Medtronic MiniMed Inc..Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management. Recall Number Z-2442-2015 REASON Medtronic MiniMed is recalling...
Read More
Company:GE Healthcare.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations,...
Read More
Company:GE Healthcare.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include...
Read More
Company:Carestream Health Inc.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. Recall Number Z-2449-2015 REASON Carestream became aware of an issue with...
Read More
Company:Brainlab AGDate of Enforcement Report: 9/2/2015 Class lI: PRODUCT ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Recall Number Z-2440-2015 REASON ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect...
Read More
http://www.softwarecpr.com/feedbackframepage.htm
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

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.