/docs/FDAComputationalModelsDraftGuidance0114.pdfRead More

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Company: Covidien. Date of Enforcement Report:1/15/2014 Class lI: PRODUCT Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014 REASON Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions...Read More

Company: EOS Imaging Date of Enforcement Report:1/15/2014 Class lI: PRODUCT EOS System X- ray beam Digital radiography system used in general radiographic examinations. Recall Number Z-0529-2014 REASON EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from...Read More

Company: Welch Allyn Protocol, Inc Date of Enforcement Report:1/15/2014 Class lI: PRODUCT The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate...Read More

Company: Carestream Health Inc. Date of Enforcement Report:1/15/2014 Class lI: PRODUCT Carestream DRX-Revolution Mobile X-Ray System — Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 — The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products...Read More

Lisa Simone, a biomedical software engineer at FDA, published an article in the Biomedical Instrumentation & Technology Journal (Nov-Dec 2013) with information on an analysis of historical software related recalls using internal information at FDA as well as other sources. The article breaks down the recalls by year and product type. She investigated the years...Read More

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The International Telecommunication Union (ITU) has adopted the Continua Design Guidelines (CDG) that contain specifications to ensure the interoperability of devices used for applications monitoring personal health (Recommendation ITU-T H.810 Interoperability design guidelines for personal health systems). ITU-T H.810 is available at the link provided: http://www.itu.int/rec/T-REC-H.810-201312-IRead More

The Association for the Advancement of Medical Instrumentation selected Alan Kusinitz (Managing Partner of SoftwareCPR) to join its board member nominating committee. Alan has contributed to standards development and training programs for AAMI over many years in the interest of protecting public health.Read More

Company:Covodien. Date of Enforcement Report:1/9/2014 Class l: PRODUCT Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG._x000D_ _x000D_ The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014 REASON Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop...Read More

http://www.nist.gov/itl/upload/preliminary-cybersecurity-framework.pdfRead More

Company: GE Healthcare It Date of Enforcement Report: 1/8/2014 Class lI: 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...Read More

Company: Nipro Diganostics Date of Enforcement Report:1/6/2014 Class lI: PRODUCT TRUEbalance and TRUEtrack blood glucose meters distributed in the U.S., Europe, Asia and Canada, the company said Thursday. REASON The affected meters ? 501 TRUEbalance and 105 TRUEtrack ? may have a flaw in the factory-set unit of measure that would cause them to measure...Read More

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The U.S. Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) maintains a website at the link provided. This website includes information and updates on Health IT and Electronic Medical Records programs for software that often is not considered a Medical Device and not regulated by the U.S. FDA.Read More

IECEE published Document OD-2044 Ed. 2.2, Evaluation of Risks Management in medical electrical equipment according to IEC 60601-1 and IEC/ISO 80601-1. The procedure intends to provide a uniform approach to the Certification Body Testing Laboratory and Manufacturer on assessment and documentation of compliance with the relevant clauses of IEC 60601 standard series related to the...Read More

Company: Data Innovations, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004 Recall Number Z-0571-2014 REASON When connected to the Sysmex UF-100, the...Read More

Company: Varian Medical Systems, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation. Recall Number Z-0552-2014 REASON An anomaly...Read More

Company: Mckesson Information Solutions LLC Date of Enforcement Report:1/1/2014 Class lI: PRODUCT McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). Recall Number Z-0556-2014 REASON When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record. RECALLING FIRM/MANUFACTURER Mckesson...Read More

Company: EOS Imaging Date of Enforcement Report:1/1/2014 Class lI: PRODUCT steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images. Recall Number Z-0580-2014 REASON Error copying information to...Read More

Company:CareFusion 303, Inc.. Date of Enforcement Report:1/1/2014 Class l: PRODUCT Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia)...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement 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: Roche Diagnostics Operations, Inc. Date of Enforcement Report:12/25/2013 Class lI: PRODUCT MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report:12/25/2013 Class lI: PRODUCT Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall Number Z-0519-2014 REASON Beckman Coulter is initiating a recall for the...Read More

AAMI announced that TIR45-2012 “Guidance on the use of agile practices in the development of medical device software” was their most popular TIR for 2013. This document was developed with the participation of FDA and addresses how Agile Methods can be use in compliance with FDA medical device regulations for software. Brian Pate and Alan...Read More

http://in.reuters.com/article/2013/12/18/cyberattack-fda-drugmakers-idINDEE9BH00N20131218Read More

Company: Iba Dosimetry Gmbh Date of Enforcement Report:12/18/2013 Class lI: PRODUCT iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological Recall Number Z-0456-2014 REASON The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation....Read More

Company: Omnyx Llc Date of Enforcement Report:12/18/2013 Class lI: PRODUCT Digital Pathology System (DPS) Software version 1.1 The Omnyx” Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx” products are for...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 12/18/2013 Class lI: PRODUCT GE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters...Read More

Company: SCC Soft Computer Date of Enforcement Report:12/18/2013 Class lI: PRODUCT SoftBank II versions: 23.1, 23.2, 25.0, 25.1, 25.2, and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x Recall Number B-0216-14 REASON Blood Bank software with a defect or glitch, was distributed.. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwataer, FL on 11/11//2013. Voluntary: Firm Initiated...Read More

Company: Cincinnati Sub-Zero Products Inc Date of Enforcement Report:12/11/2013 Class lI: PRODUCT Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT syngo(R) Lab Data Manager – Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help...Read More

Company: GE Healthcare It Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Reloaded Vista Vials – limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids. Recall Number Z-0430-2014 REASON There is the potential...Read More

Company: Haemonetics Software Solutions Date of Enforcement Report:12/11/2013 Class lI: PRODUCT ElDorado Donor Doc Software, comprehensive donor health qualification computer system, run in a native Internet Explorer browser that is displayed in kiosk mode. Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0 Recall Number B-0008-14 REASON Blood Bank Software, with a defect or glitch, was...Read More

The International Medical Device Regulators Forum (IMDRF) issued a final document “Software as a Medical Device(SaMD): Key Definitions” on December 9, 2013. IMDRF SaMD defRead More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:12/4/2013 Class lI: PRODUCT (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system Recall Number Z-0140-2014 REASON A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos...Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:12/4/2013 Class lI: PRODUCT (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system Recall Number Z-0374-2014 REASON A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos...Read More

Company: Custom Ultrasonics, Inc. Date of Enforcement Report:12/4/2013 Class lI: PRODUCT Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. Recall Number Z-0426-2014 REASON Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. RECALLING FIRM/MANUFACTURER Custom Ultrasonics, Inc.,...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 12/4/2013 Class lI: PRODUCT ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System) The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger....Read More

Company: Siemens Healthcare Diagnostics Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.Recall Number Z-0343-2014, Z-0344-2014, Z-0345-2014, Z-0346-2014 REASON iemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to...Read More

Company: GE Healthcare It Date of Enforcement Report: 11/27/2013 Class lI: 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...Read More

Company: Spacelabs Healthcare, Llc Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment...Read More

Company:Philips Medical Systems North America Inc. Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis. Recall Number Z-0368-2014 REASON A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International...Read More

Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians...Read More

http://mobihealthnews.com/27563/in-tense-hearing-congressman-declares-software-is-not-a-medical-device/Read More

Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians...Read More

Company: GE Healthcare, LLC Date of Enforcement Report:11/27/2013 Class ll: PRODUCT GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating...Read More

Company: Hospira Inc Date of Enforcement Report: 11/25/2013 Class l: PRODUCT Hospira GemStar Infusion System Models 13000, 13100, 13150, 13086, 13087, 13088 The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous,...Read More