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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...
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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,...
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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...
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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...
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Recipient: Beckman Coulter, Inc.Product: Class II diagnostic chemistry analyzers, reagents, calibrators and controls Date: 8/9/2011 Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of...
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Company: Blood Bank Computer Systems, Inc.Date of Enforcement Report 8/17/11 Class ll: PRODUCT Blood Bank Computer Service (BBCS) Mobile Application (versions) 5.0M, 5.1M, and 5.1.1M. The device is a software application used by blood banking firms to track donor information at remote sites to eventually link up with the Primary Application that is linked to...
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Recipient: Spinetronics, LLC .Product: Antalgic-Trak Date: 7/25/2011 Violations include, but are not limited to, the following: 1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example: You do not have design control procedures....
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Company: Hitachi Medical Systems America Inc.Date of Enforcement Report 8/10/11 Class ll: PRODUCT Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software – Doppler Trace Measurement program. 510 (k) Numbers: Preirus – K093466 (6/1/10), Avius – K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound...
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Company: Micro Typing Systems, Inc.Date of Enforcement Report 8/10/11 Class ll: PRODUCT ORTHO Pro Vue, Software Version 3.1. Upon turning the ORTHO Pro Vue on, the screen that appears immediately after the log in screen is the one that contains the Software Version. Software version is located in the upper right hand corner of the...
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Company: AGFA Corp.Date of Enforcement Report 8/10/11 Class ll: PRODUCT IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting. Recall # Z-2552-2011 REASON Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper...
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Company: Capsule TechnologiDate of Enforcement Report 8/3/11 Class ll: PRODUCT Capsule Neuron UMPC is a component in the DataCaptor” Connectivity System. Catalog Number: DC-NU-MPC Capsule Neuron” UMPC is a bedside device that enables automatic collection of vital signs data that can local cache data and connect to the hospital network through a wired Ethernet connection...
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Company:Instrumentation Laboratory Co. Date of Enforcement Report 8/3/11 Class ll: PRODUCT Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000. The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting....
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Company:WaveLight AG Date of Enforcement Report 8/3/11 Class ll: PRODUCT WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and...
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Company:Computerized Medical Systems Inc. Date of Enforcement Report 8/3/11 Class ll: PRODUCT XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above. Recall # Z-2604-2011 REASON XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to...
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Company:Baxter Healthcare Corp. Date of Enforcement Report 8/3/11 Class ll: PRODUCT LOGIX Order Entry (OE) Software, all versions, catalog 2M8410. The software is included in a number of Baxter’s pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration. Recall # Z-2291-2011. REASON The LOGIX...
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Company:Beckman Coulter Inc Date of Enforcement Report 8/3/11 Class ll: PRODUCT 1) Beckman Coulter UniCel DxI 800 Access Immunoassay System with UniCel DXI system software version 4.3. Part Numbers: A71456, 973100, A25288, A25285. Recall # Z-2685-2011; 2) Beckman Coulter UniCel DxI 600 Access Immunoassay System, Part Numbers: A71460 and A30260 with UniCel DXI system. Recall...
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Company:Computerized Medical Systems Inc. Date of Enforcement Report 8/3/11 Class ll: PRODUCT XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2407-2011 REASON XiO Software: For a specific clinical setup, the MLC...
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Company:Newport Medical Instruments Inc. Date of Enforcement Report 8/3/2011 Class ll: PRODUCT Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous (endotracheal or tracheotomy [ET] tube) or non-continuous (mask) ventilator support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters...
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Company:Spacelabs Healthcare, LLC Date of Enforcement Report 8/3/11 Class ll: PRODUCT Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: “***Pathfinder Holter Analyzer. The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect...
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Company:Medtronic Navigation, Inc Date of Enforcement Report 8/3/11 Class ll: PRODUCT DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933. DICOM Query/Retrieve software is installed on Medtronic StealthStation systems. Product Usage: DICOM Query/Retrieve software enables the user to query a hospital Picture...
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Company:Brentwood Medical Technology Corp Date of Enforcement Report 8/3/11 Class ll: PRODUCT ) IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. Recall # Z-2724-2011; 2) IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2 Product...
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Company:Computerized Medical Systems Inc. Date of Enforcement Report 8/3/11 Class ll: PRODUCT Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioactive seed implantation. Recall # Z-2622-2011 REASON Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in...
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Company:Mettler Electronics Corp. Date of Enforcement Report 8/3/11 Class ll: PRODUCT MTD 4000 – Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles. Recall # Z-2580-2011 REASON The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection...
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Company:Eos Imaging Date of Enforcement Report 8/3/11 Class ll: PRODUCT EOS system is a digital radiography system used in general radiographic examinations. sterEOS workstation is a medical image review station for acceptance, transfer, display, storage, and digital processing of 2D X-ray images. Recall # Z-2692-2011 REASON Print true size, print requests from the EOS acquisition...
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Company: Computerized Medical Systems Inc. Date of Enforcement Report 8/3/11 Class ll: PRODUCT Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: 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...
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Company:Impac Medical Systems Inc., . Date of Enforcement Report 7/27/2011 Class ll: PRODUCT Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. It gives the capability...
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Company:SCC Soft Computer Date of Enforcement Report 7/27/2011 Class ll: PRODUCT ElekSoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries,...
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FDA issued an analysis of Premarket Review Times under the 510(k) Program. In two samples of submissions it analyzed software deficiencies in the submissions were noted in 14-20% of the submissions analyzed. The deficiencies included no software documenation provided, missing software description, missing trace matrix, missing list of anomalies, and/or missing validation. In addition form...
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Company:Computerized Medical Systems Inc. Date of Enforcement Report 7/13/2011 Class ll: PRODUCT Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2561-2011. REASON Monaco: For VMAT...
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Company:St Jude Medical CRMD. Date of Enforcement Report 7/13/2011 Class ll: PRODUCT SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia. Recall # Z-2733-2011 REASON The recall was...
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Company:Philips Healthcare Inc. Date of Enforcement Report 7/6/2011 Class ll: PRODUCT Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/6/2011 Class ll: PRODUCT ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist Express Basic Part number 08515289; syngo RT Therapist Part Number 08162815; and syngo RT Therapist Connect/MOSAIQ OIS Part number 08168754. The ONCOR and PRIMUS may be...
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Company:Lockheed-Martin Aculight Date of Enforcement Report 7/6/2011 Class ll: PRODUCT Lockheed Martin Aculight Capella-r 1850 Laser. The Capella Laser is intended for use in user-defined scientific applications and non-human-use research on infrared nerve stimulation. Recall # Z-2069-2011 REASON It has been determined that there are certain software driven operating sequences involving off-on cycling of the...
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Company:AGFA Copr.Date of Enforcement Report 7/6/2011 Class ll: PRODUCT NX is the radiographer’s image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for...
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Company:International Technidyne Corp. Date of Enforcement Report 7/6/2011 Class ll: PRODUCT a) AVOXimeter 1000, b) AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use in the cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable...
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Company:AGFA Corp Date of Enforcement Report 7/6/2011 Class ll: PRODUCT IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into...
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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...
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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...
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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...
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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,...
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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,...
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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:...
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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...
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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...
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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,...
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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....
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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...
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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...
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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...
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