Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2013 Class ll: PRODUCT GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging. Recall Number Z-0024-2014 REASON GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved...Read More

Our test team at SoftwareCPR® often uses Ranorex Automated Test Tool for automated integration level and software system level testing.   We have had very good experience with this tools for user interface testing for certain types of medical device software.  The test reports are particularly impressive and well suited for Design History Files (DHF). Accelerate testing...Read More

http://1.usa.gov/1e876ZQRead More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#ruleguidancRead More

Last week was the first offering of AAMI’s course on Agile Software Methods Compliance. Approximately 30 students attended from a wide range of medical device manufacturers including software engineers, quality, compliance, and regulatory managers. As a first offering this level of enrollment shows the high interest in more efficient and effective approaches to medical device...Read More

Company:Hologic Inc. Date of Enforcement Report: 10/9/2013 Class ll: PRODUCT Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use...Read More

Company: Mckesson Information Solutions LLC Date of Enforcement Report: 10/9/2013 Class ll: PRODUCT McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information...Read More

Company: Codman & Shurtleff, Inc. Date of Enforcement Report: 10/2/2013 Class l: PRODUCT MedStream Programmable Pump; 20ml – 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/2/2013 Class ll: PRODUCT GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T....Read More

Company: Elekta Inc. Date of Enforcement Report: 10/2/2013 Class ll: PRODUCT Monaco RTP System Radiation treatment planning Recall Number Z-2276-2013 REASON Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values. RECALLING FIRM/MANUFACTURER Elekta, Inc, Atlanta, GA on 7/2/2013. Voluntary: Firm Initiated recall is...Read More

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/docs/EUCOMMISSIONRECOMMENDATIONS092413.pdfRead More

The EU Commission published “Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices.” This clarifies and strengthens the criteria for certifying (and auditing) notified bodies, and the criteria that the notified bodies have to use in assessing companies and products. The main changes...Read More

HealthCanada released a FAQ sheet answering basic questions about software regulated as a medical device. The document clarifies that software regulated as a medical device is software which retrieves data from a medical device in order to aid or replace a physician’s decision regarding the diagnosis or treatment of a patient. Software that transmits data...Read More

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

The FDA Safety and Innovation Act (FDASIA) workgroup completed its work and made its draft recommendations in September. The recommendations include: HIT should not be regulated except in cases where there is risk to the patient, a patient-safety risk framework should be used to allow application of regulatory oversight by risk, vendors should be required...Read More

Company: B Braun Medical, Inc. Date of Enforcement Report: 9/25/2013 Class l: 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

Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. Recall Number Z-2241-2013 REASON GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed. RECALLING FIRM/MANUFACTURER GE Healthcare,...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

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

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

/docs/FDA-eSourceDataGuidance.pdfRead 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: 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: 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

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

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: 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

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

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: 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

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

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