Company:Dept Of Veterans Affairs Office Of Information & Technology Date of Enforcement Report 6/29/2011 Class ll: PRODUCT VistA Blood Establishment Computer Software (VBECS) version 1.0. Recall # B-1496-11 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Dept Of Veterans Affairs Office Of Information & Technology, Hines, IL, by letter on March 17,...Read More

Company:Computerized Medical Systems Inc Date of Enforcement Report 6/29/2011 Class ll: PRODUCT Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2564-2011 REASON Monaco: due to a software defect, the Radiological...Read More

Company:Varian Medical Systems Date of Enforcement Report 6/29/2011 Class ll: PRODUCT Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon,...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 6/29/2011 Class ll: PRODUCT BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 6/29/2011 Class ll: PRODUCT ARTISTE, ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US...Read More