Company: Computerized Medical Systems Inc.Date of Enforcement Report 8/24/11 Class ll: PRODUCT XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2593-2011 REASON XiO Software: The Patient Scan position is being confused...Read More

Company: Computerized Medical Systems Inc.Date of Enforcement Report 8/31/11 Class ll: PRODUCT XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. Recall...Read More

Company: Siemens Medical Solutions, USA, Inc.Date of Enforcement Report 8/24/11 Class ll: PRODUCT syngo Dynamics Picture Archiving Communication System. The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation. Recall # Z-2762-2011 REASON For systems upgraded to syngo...Read More

Company: Computerized Medical Systems Inc.Date of Enforcement Report 8/24/11 Class ll: PRODUCT Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 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-2569-2011 REASON Monaco: In XiO IMRT (Dynamic MLC Delivery) software,...Read More

Company: Computerized Medical Systems Inc.Date of Enforcement Report 8/24/11 Class ll: PRODUCT Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with...Read More

Company: Computerized Medical Systems Inc.Date of Enforcement Report 8/24/11 Class ll: PRODUCT Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with...Read More