Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and...Read More

/docs/FDAMMAppFinalGuidance0913.pdfRead More

The Therapeutic Goods Administration of the Australian Department of Health released a document on 13-Sep-2013 entitled “Regulation of medical software and mobile medical ‘apps’.”  This explains at a high level Australia’s approach to regulation of medical software.  It indicates a risk based approach is taken and that all medical devices are expected to meet the...Read More

Company: B Braun Medical, Inc. Date of Enforcement Report: 9/18/2013 Class lI: PRODUCT Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative...Read More

General Hearing Instruments, Inc.. Product: ready-wear-air conduction hearing aids Date: 9/18/2013 This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC Section 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current...Read More

/docs/FDA-eSourceDataGuidance.pdfRead More

Company: Nidek Inc. Date of Enforcement Report: 9/11/2013 Class llI: PRODUCT WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes. Recall Number Z-2131-2013 REASON The recall of the WASP (Walk Away...Read More

Company: Data Innovations. Date of Enforcement Report: 9/11/2013 Class ll: PRODUCT 1. Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002 Recall Number B-2265-13 2. Data Innovations Instrument Manager software Model – Versions 8.12.01 Recall Number B-2299-13 REASON Laboratory software, with a defect...Read More

Company:Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 9/4/2013 Class ll: PRODUCT Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes...Read More

Company: MCKESSON TECHNOLOGIES INC. Date of Enforcement Report: 9/4/2013 Class ll: PRODUCT Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures. Recall Number Z-2089-2013 REASON The firm issued a clinical alert after users reported an...Read More

Company: Nidek Inc. Date of Enforcement Report: 9/4/2013 Class ll: PRODUCT NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. Recall Number Z-2046-2013 REASON Under certain circumstances, the Left eye image may be saved as the Right eye...Read More

Jabones Pardo S.A..Product: pharmaceutical manufacturing facility Date: 8/22/2013 an investigator from the U.S. 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 Section...Read More

Company: GE Healthcare, LLC Date of Enforcement Report:9/4/2013 Class ll: PRODUCT GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports...Read More

The link provided is to a YouTube video by Henrik Kniberg on Agile Methods on key concepts focused on product ownership. Youtube – Agile MethodsRead More

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures. Recall Number Z-1956-2013 REASON Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and...Read More

Company: Carestream Health Inc. Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT Carestream DRX Evolution System, X-ray system — The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Recall Number Z-1877-2013 REASON To a potential for an x-ray exposure technique change. RECALLING FIRM/MANUFACTURER Carestream...Read More

Company: Veridex, LLC Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT 1. CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology...Read More

FDA CDRH has increased its focus on networked medical devices, Health IT, wireless technologies, and telemedicine.  They have established a web page provide an overview which then has links to pages related to Mobile Medical Apps, Medical Device Data Systems, Home Health and Consumer Device, Health IT, and wireless medical devices.Read More

Company: bioMerieux Inc. Date of Enforcement Report: 8/14/2013 Class ll: PRODUCT bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial...Read More

/docs/FDARadioFrequencyWirelessTechnologyGuidance.pdfRead More

Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK Date of Enforcement Report: 8/14/2013 Class ll: PRODUCT MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in...Read More

/docs/FDA-WirelessMedicalDeviceGuidance091413.pdfRead More

/docs/FDA-WirelessMedicalDeviceGuidance091413.pdfRead More

Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit Company: Iradimed Corporation Date of Enforcement Report: 8/12/13 Date Recall Initiated: 7/1/2013 Class l: PRODUCT MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium...Read More

Company:Picis Inc. Date of Enforcement Report:8/7/2013 Class ll: PRODUCT Picis ED Pulsecheck – EMR Software Application – 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes. Recall Number Z-1814-2013 REASON Notes...Read More

Company: Hospira Inc. Date of Enforcement Report: 8/7/2013 Class ll: PRODUCT The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. Recall Number Z-1847-2013 REASON The devices secondary audio signal fails to...Read More

Company:Beckman Coulter Inc. Date of Enforcement Report: 8/7/2013 Class ll: PRODUCT AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only. Recall Number Z-1834-2013 REASON The recall was initiated because Beckman Coulter has identified a software error on...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/7/2013 Class ll: PRODUCT GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid...Read More

FDA has recognized a total of 25 standards on medical device interoperability and cybersecurity. These standards can be categorized into 3 groups: Risk management standards for a connected and networked environment (IEC 80001 series and ASTM F2761-09) Interoperability standards that establish nomenclature, frameworks, and medical device specific communications, including system and software lifecycle processes (ISO/IEEE...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system. Recall Number Z-1782-2013 REASON Siemens issued a customer safety advisory notice and field safety corrective action for...Read More

Company: Del Mar Reynolds Medical, Ltd. Date of Enforcement Report: 7/31/2013 Class lI: PRODUCT Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used...Read More

Company:Topcon Medical Laser Systems, Inc Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient’s eye. Recall Number Z-1774-2013 REASON When using the “Favorites” function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over...Read More

Company:Blood Bank Computer Systems, Inc. Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT Blood Bank software Primary Application with Model numbers 5.4.0.2 and 5.4.1. Recall Number B-2148-13 REASON Blood Bank software Primary Application (Model Numbers 5.4.0.2 and 5.4.1), with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc., Auburn, WA on...Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report: 7/24/2013 Class ll: PRODUCT RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of...Read More

Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report: 7/24/2013 Class ll: PRODUCT CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired....Read More

Company: Technidata S.A. Date of Enforcement Report: 7/24/2013 Class llI: PRODUCT TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S) Recall Number Z-1743-2013 REASON A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other...Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report: 7/24/2013 Class ll: PRODUCT Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such...Read More

/docs/SCPRed/SoftwareCPR-newsletter0713.pdfRead More

ICS-CERT is issuing this alert to provide early notice of a report of a hard-coded password vulnerability affecting roughly 300 medical devices across approximately 40 vendors. The document can be viewed at the following link: ICS-CERT_alert_med_devRead More

ONC contract with the Joint Commission to investigate health IT-related safety events. The purpose of this contract is to ensure that there is an early detection system on health IT-related safety issues, including those associated with EHRs. The document can be viewed at the following link: ONC_tjc_contractRead More

ONC guidance on annual surveillance plans by authorized certification bodies. Authorized Certification Bodies are expected to conduct surveillance on EHRs that they have certified. This guidance provides the priorities for topics to assess in the surveillance plan. Safety-related capabilities and security capabilities are two of the four areas for priority identified in this guidance. onc_surveillance_plan_guidanceRead More

NIST was directed to prepare a cybersecurity framework for critical infrastructure in Presidential Executive Order 13636. Healthcare was identified as one of the areas with critical infrastructure. This draft for comment is only an outline of the framework. NIST_draft_outline_cybersecurity_frameworkRead More

The final version of the ONC plan that has the objectives to use health IT to make care safer and to continuously improve the safety of health IT. The document can be viewed here: onc_patient_safety_planRead More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 7/10/2013 Class ll: PRODUCT Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken...Read More

http://1.usa.gov/1cwC5g2Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 7/3/2013 Class ll: PRODUCT Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission. Recall Number Z-1588-2013 REASON If the operator selects a patient name...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 7/3/2013 Class ll: PRODUCT CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system...Read More

Company: GE Healthcare ITDate of Enforcement Report: 7/3/2013 Class ll: PRODUCT The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed...Read More