Company:Computerized Medical Systems Inc Date of Enforcement Report 6/22/2011 Class ll: PRODUCT XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2567-2011 REASON XiO Software: Under certain conditions, when the port shape...Read More

Company: Varian Medical Systems, Inc. Date of Enforcement Report 6/22/2011 Class ll: PRODUCT Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions....Read More

Company: Toshiba American Medical Systems Inc. Date of Enforcement Report 6/22/2011 Class ll: PRODUCT Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound. Recall # Z-2203-2011. REASON Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in...Read More

Company: Toshiba American Medical Systems Inc. Date of Enforcement Report 6/22/2011 Class ll: PRODUCT CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed. Recall # Z-2204-2011 REASON The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being...Read More

Company: Varian Medical Systems, Inc. Date of Enforcement Report 6/22/2011 Class ll: PRODUCT Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, For use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions. Recall # Z-2200-2011. REASON A software anomaly...Read More

Company:GE Healthcare IT, Date of Enforcement Report 6/22/2011 Class ll: PRODUCT GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software. The Centricity Laboratory is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with...Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report 6/22/2011 Class ll: PRODUCT ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software. The intended use is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ARTIST Systems include:...Read More

Company: Radiometer America Inc. Date of Enforcement Report 6/22/2011 Class ll: PRODUCT ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose,...Read More