Company:Toshiba American Medical Systems Inc. Date of Enforcement Report 9/5/12 Class ll: PRODUCT EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy. Z-2278-2012 REASON The status display in the...Read More

Company:Cisco Systems Date of Enforcement Report 9/5/12 Class ll: PRODUCT Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a...Read More

Company:I-Flow Corporation Date of Enforcement Report 8/31/12 Class l: PRODUCT ON-Q Pump with ONDEMAND Bolus Button. The I-Flow ON-Q pump with ONDEMAND bolus button was manufactured from October 18, 2002 through April 30, 2012 and distributed from May 3, 2010 through May 1, 2012 Use: The On-Q pump with ONDEMAND bolus button is used for...Read More

Company:Baxter Healthcare Corp. Date of Enforcement Report 8/29/12 Class l: PRODUCT Product Name Product Codes Serial Numbers Automix High Speed Compounder System 2M8077 All Automix Plus High Speed Compounder System 2M8075 All Automix 3+3 Compounder System 2M8286 and 2M8286K All Automix 3+3 Compounder System with Accusource Monitoring System 2M8287 All Range of Manufacturing and Distribution...Read More

Company:achi Medical Systems America Inc Date of Enforcement Report 8/29/12 Class ll: PRODUCT Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination. Z-2254-2012 REASON...Read More

Company:Sunquest Information Systems, Inc. Date of Enforcement Report 8/29/12 Class lll: PRODUCT Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. Recall Number Z-2243-2012 REASON Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than...Read More

Company:AGFA Corp. . Date of Enforcement Report 8/29/12 Class ll: PRODUCT AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device .Recall Number Z-2252-2012 REASON Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa’s Medical...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 8/29/12 Class ll: PRODUCT UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination...Read More

Company:AGFA Corp. . Date of Enforcement Report 8/22/12 Class ll: PRODUCT IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) All software versions. Recall Number Z-2184-2012 REASON Content entered into the “Conclusions” free text box on the Report Writer screen was not represented...Read More

Company:Philips Healthcare Inc. Date of Enforcement Report 8/22/12 Class ll: PRODUCT Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use. Z-2208-2012 REASON Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 8/22/12 Class ll: PRODUCT GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced...Read More

FDA issued a list of modifications to its standards recognitions. The link provided is the webpage where FDA posts each modification list.Read More

Company:rian Medical Systems, Inc. Oncology Systemsr Date of Enforcement Report 8/15/12 Class ll: PRODUCT Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and...Read More

Company:SCC Soft Computer Date of Enforcement Report 8/15/12 Class ll: PRODUCT SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for...Read More

The final version of “ANSI/AAMI SW 87:2012 Application of quality management system concepts to medical device data systems” has been published. FDA initiated and participated in this work. Sherman Eagles, Sandy Hedberg, and Molly Ray of SoftwareCPR were on the working group and Alan Kusinitz of SoftwareCPR was a reviewer. SoftwareCPR can provide MDDS developers...Read More

Company:GE OEC Medical Systems, Inc Date of Enforcement Report 8/8/12 Class ll: PRODUCT OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room...Read More

Company: Smiths Medical ASD, Inc. Date of Enforcement Report 8/2/12 Date Recall Initiated: February 14, 2012 Class l: PRODUCT Smiths Medical Medfusion 4000 Syringe Infusion Pump.The Medfusion 4000 is a wireless, electronic infusion pump used to provide intravenous (IV) infusions of fluids, medications, blood, and blood products to adult, pediatric, and neonatal patients.Z-2107-2012 Distribution Dates:...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 8/1/12 Date Recall Initiated: May 25, 2012 Class l: PRODUCT Alaris PC unit, model 8015 with PC unit power supply board P/N TC10005122, manufactured after January 2011. Affected product was distributed from January 1, 2011, to May 31, 2012. The Alaris PC unit, model 8015 is part...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/112 Class ll: PRODUCT ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of...Read More

Company:Ortho-Clinical Diagnostics Date of Enforcement Report 8/112 Class ll: PRODUCT VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. Z-2066-2012 REASON software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually...Read More

Company:AGFA Corp. Date of Enforcement Report 8/112 Class ll: PRODUCT IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view,...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/112 Class ll: PRODUCT Siemens syngo.plaza. Radiological image processing system. Z-2078-2012 REASON Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message...Read More

/docs/SCPRed/SoftwareCPR-Newsletter0712.pdfRead More

Company:GE Healthcare Date of Enforcement Report 7/25/12 Class ll: PRODUCT GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR ) Recall Number Z-1993-2012 REASON GE Healthcare hos become aware of o software issue on the interfoce of the...Read More

Company:Sigma Date of Enforcement Report 7/25/12 Class lll: PRODUCT SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters. Recall Number Z-2030-2012 REASON Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with...Read More

Company:Hitachi Medical Systems America Inc. Date of Enforcement Report 7/25/12 Class ll: PRODUCT Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the...Read More

Company:Philips Healthcare Date of Enforcement Report 7/23/12 Philips Healthcare Recalls Faulty Patient Data Exchange System Philips Healthcare is recalling a faulty patient data exchange system after finding that the tool sometimes sent incomplete cardiology reports to patients’ electronic health records, the Wall Street Journal’s “CIO Journal” reports. About the Problem The issue occurred when clinicians...Read More

Company:superDimension, Inc Date of Enforcement Report 7/18/12 Class ll: PRODUCT superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a...Read More

Company:Philips Healthcare Inc. Date of Enforcement Report 7/18/12 Class ll: PRODUCT Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in...Read More

Company:Philips Medical Systems Date of Enforcement Report 7/18/12 Class ll: PRODUCT Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Recall Number Z-1988-2012 REASON Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances....Read More

Company:GE OEC Medical Systems, Inc. Date of Enforcement Report 7/18/12 Class ll: PRODUCT InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may...Read More

Company:Philips Medical Systems Date of Enforcement Report 7/18/12 Class ll: PRODUCT IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation. Z-1987-2012...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 7/18/12 Class ll: PRODUCT GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission...Read More

Company:Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 7/18/12 Class ll: PRODUCT Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from...Read More

FDA released a new guidance dated July 3, 2012 entitled ” Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions. This guidance discusses types of Computer Aided Detection devices (CADe) and appropriate clinical data to include in 510(k)s and...Read More

Company:Philips Healthcare IncDate of Enforcement Report 7/11/12 Class ll: PRODUCT Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine...Read More

Company:Maquet Medical Systems USA Date of Enforcement Report 6/18/12 Date Recall Initiated: February 20, 2012 Class l: PRODUCT FLOW-i Anesthesia System (software) REASON A technical alarm may be generated on the FLOW-i system when using the Manual/Automatic (MAN/AUTO) switch to change ventilation modes from manual to automatic or from automatic to manual if the switch...Read More

The link provided is to the Official US Government Web Site for the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs. The terms EHR and Electronic Medical Record(EMR) are sometimes used interchangeably. The issue of what systems FDA does now or might in the future regulate as a medical device is not addressed via...Read More

Medical Device Interoperability Coordinating Council draft concept paper is at the link provided. This group is being facilitated by the FDA to encourage interoperability between medical devices. MDICC Draft ConceptRead More

This link provides a ten-year strategy document for information technology use in healthcare in England. NHS Power of InformationRead More

Company:Spacelabs Healthcare, LLC.Date of Enforcement Report 6/27/12 Class ll: PRODUCT The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In...Read More

The pdf at the link provided contains slides from a presentation by Brian Pate providing an overview of the soon to be released “Agile Methods for Medical Device Software Development” Technical Information Report (TIR). These slides focus on the TIR. We have posted another slide set in our library with some training slides on SoftwareCPR...Read More

Company:SIGMA International, LLCDate of Enforcement Report 6/18/12 Date Recall Initiated: July 6, 2011 Class l: PRODUCT SIGMA Spectrum Infusion Pump Model 35700. The SIGMA Spectrum Infusion Pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products through parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration....Read More

Recipient:  Shamrock Medical Solutions Group LLC . Product:  Pharmeceuticals Date: 6/15/2012 Investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of...Read More

Recipient:  American Optisurgical Inc. Product:  TX1 Tissue Removal System Date: 6/14/2012 This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act [21 U.S.C. § 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity...Read More

Company:Philips Medical Systems (Cleveland) Inc.Date of Enforcement Report 6/13/12 Class ll: PRODUCT The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/6/12 Class ll: PRODUCT 1) Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 – ACUSON S2000 Mainframe; The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic...Read More

Company:Becton Dickinson & Co..Date of Enforcement Report 6/6/12 Class ll: PRODUCT 1) Becton Dickinson Phoenix” System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram...Read More

Company:Computerized Medical Systems Inc.Date of Enforcement Report 6/6/12 Class ll: PRODUCT XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within...Read More

Company:Ortho-Clinical Diagnostics.Date of Enforcement Report 6/6/12 Class ll: PRODUCT VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Product...Read More