Company:SCC Soft Computer Date of Enforcement Report 1/11/12 Class ll: PRODUCT SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of...Read More

Company:SCC Soft Computer Date of Enforcement Report 1/11/12 Class ll: PRODUCT SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. Product Usage: SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing...Read More

Company:AGFA Corp Date of Enforcement Report 1/11/12 Class ll: PRODUCT IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2. Recall # Z-0211-2012 REASON Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable. RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by letter dated May...Read More

Company:Philips Medical Systems Date of Enforcement Report 1/11/12 Class ll: PRODUCT Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data. Model Number 882488: EBW NM Special Model...Read More

Company:Philips Medical Systems Ibc. Date of Enforcement Report 1/11/12 Class ll: PRODUCT 1) Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243. The recalled device systems are equipped with Version 3.5 Beta 1 software. Recall # Z-0334-2012; 2) Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231. The recalled device...Read More