Company: Varian Medical Systems Oncology Systems Date of Enforcement Report 10/8/2008 Class:ll PRODUCT Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments, Recall # Z-2308-2008 REASON Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters. RECALLING...Read More

Company: Varian Medical Systems Oncology Systems Date of Enforcement Report 10/8/2008 Class:ll PRODUCT Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48, Recall # Z-1612-2008 REASON A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan. RECALLING FIRM/MANUFACTURER Recalling Firm: Varian Medical Systems Oncology Systems, Palo...Read More

Company: SCC Soft Computer Date of Enforcement Report 10/8/2008 Class:ll PRODUCT SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases, Recall # Z-2329-2008 REASON Loss of text misrepresented individual tissue diagnosis on the final diagnosis print...Read More

Company: SCC Soft Computer Date of Enforcement Report 10/8/2008 Class:ll PRODUCT SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3, Recall # Z-2463-2008 REASON In the creation of revised report and supplemental reports diagnosis, text was inserted from another case. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL, by letter beginning February 23, 2006. Firm initiated...Read More

Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 10/8/2008 Class:ll PRODUCT GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis, Recall # Z-2183-2008 REASON When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload...Read More

Company: Abaxis Inc. Date of Enforcement Report 10/8/2008 Class:ll PRODUCT a) Piccolo Chemistry Analyzer software version 6.121. Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self- contained reagent disk, intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination., Recall # Z-2286-2008; b) Piccolo Chemistry...Read More