http://www.nist.gov/cyberframework/.Read More

http://www.healthit.govRead More

The Office of National Coordinator for Health Information Technology published a proposed rule for Voluntary 2015 Edition Electronic Health Record Certification Criteria; Interoperability Updates and Regulatory Improvements. The proposed rule eliminates the “complete EHR” designation, separates the content and transport certification criteria and announces a more frequent certification rule making process. The proposed rule also...Read More

There is a new draft for vote of ISO 13485 Medical Devices – Quality Management systems – requirements for regulatory purposes. This version updates the references to ISO 9001 to the 2008 version. Some new requirements include: A requirement for a risk management process has been added in the product realization phase and ISO 14971...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 3/5/2014 Class lI: PRODUCT GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report:3/52014 Class lI: PRODUCT M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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...Read More

/docs/FDApresubmissionFeedbackGudiance.pdfRead More

http://tinyurl.com/n23tt3jRead More

Company:Elekta, Inc.Date of Enforcement Report:2/26/2014 Class lI: PRODUCT Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs – (1) You do an online VolumeView acquisition and registration. (2) You accept the...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 2/26/2014 Class lI: PRODUCT GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means...Read More

AAMI recently published “Assessing a Hospital’s Medical IT Network Risk Management Practice with 80001-1” in Biomedical Instrumentation & Technology (BI&T). The article reports on an actual hospital network/health IT assessment using 80001-1 as one of the tools for the assessment.Read More

Sherman Eagles of SoftwareCPR co-authored AAMI’s recently published article “Reducing Risks and Recalls: Safety Assurance Cases For Medical Devices” in the January/February 2014 issue of BI&T (Biomedical Instrumentation & Technology; a monthly, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation). The full article is posted with permission at the link provided. Any...Read More

http://tinyurl.com/lqw6oyuRead More

Company:Sysmex America Inc Date of Enforcement Report:2/19/2014 Class lI: PRODUCT The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories. Recall Number Z-0949-2014 REASON The current Century...Read More

Company:Neuro Kinetics, Inc. Date of Enforcement Report:2/19/2014 Class lI: PRODUCT Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. Recall Number Z-0966-2014 REASON The data provided on the Normative Data Template CD for use with the I-Portal devices has not...Read More

Company:Ortho-Clinical Diagnostics Date of Enforcement Report:2/19/2014 Class lI: PRODUCT VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the...Read More

Company:Mckesson Information Solutions LLCDate of Enforcement Report:2/19/2014 Class lI: PRODUCT Horizon Medical Imaging, Picture Archive Communication System (PACS). Recall Number Z-0976-2014 REASON Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.. RECALLING FIRM/MANUFACTURER Mckesson Information Solutions LLC,...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/19/2014 Class lI: PRODUCT Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for...Read More

Company: Bio-Rad Laboratories, Inc. Date of Enforcement Report:2/19/2014 Class lI: PRODUCT D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale}...Read More

Company:Ortho-Clinical Diagnostics Date of Enforcement Report:2/19/2014 Class lI: PRODUCT enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides...Read More

/docs/MarsCodeFebruary2014.pdfRead More

The latest ACM Journal has an interesting article on software verification at NASA JPL for the Mars Curiosity Rover at the link provided: Mars Code February 2014Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report:2/122014 Class lI: PRODUCT Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476) Recall Number Z-0932-2014 REASON The PET Reconstruction Server (PRS)...Read More

Company: B. Braun Medical, Inc.Date of Enforcement Report:2/122014 Class lI: PRODUCT B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications. Recall Number Z-0921-2014 REASON Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 2/12/2014 Class lI: PRODUCT CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time....Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:2/12/2014 Class lI: PRODUCT Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.Recall Number Z-0907-2014 REASON During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version...Read More

Company: Stryker Medical Division of Stryker Corporation Date of Enforcement Report:2/122014 Class lI: PRODUCT The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series...Read More

Company: AGFA. Corp. Date of Enforcement Report:2/12/2014 Class lI: PRODUCT IMPAX RIS QDOC 5.8 Recall Number Z-0919-2014 REASON Patient name displayed (printed) on the Patient Report was the wrong patient name. RECALLING FIRM/MANUFACTURER AGFA. Corp., Greenville, SC. on 1/8/2014. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 14 DISTRIBUTION CA, FL, GA,...Read More

NIST received comments on the Preliminary Cybersecurity Framework for improving critical infrastructure cybersecurity and is updating the framework. They have announced that the final version (Version 1.0) will be released on February 13. When it is released, the Final Framework will be posted at NIST.Read More

A new set of guides and interactive tools to help health care providers more safely use electronic health information technology products, such as electronic health records (EHRs), are now available at the link provided. The Office of the National Coordinator for Health Information Technology (ONC) at HHS released the Safety Assurance Factors for EHR Resilience...Read More

http://www.aami.org/news/2014/020514_FDA_Overhaul_Inspection_Compliance_Activities.htmlRead More

Company: GE Healthcare LLC Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. _x000D_ _x000D_ Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0840-2014 REASON There is an issue with the...Read More

Company: Integra LifeSciences Corp.. Date of Enforcement Report:2/5/2014 Class lI: PRODUCT ntegra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA_x000D_ _x000D_ The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems._x000D_ _x000D_ Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. Recall Number Z-0800-2014 REASON An overflow flag //// is displayed in the result column for a test when the...Read More

Company: DeRoyal Industries Inc Date of Enforcement Report:2/5/2014 Class lI: PRODUCT 1. Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China._x000D_ _x000D_ Physical Therapy. Recall Number Z-0834-2014 2. DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx...Read More

Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Centricity PACS System versions 3.X and higher and 4.X and higher_x000D_ Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It...Read More

Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout...Read More

Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 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: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Siemens CentraLink” Data Management System V14.0.4, V14.0.5 or V14.0.8_x000D_ _x000D_ The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected...Read More

Company: Carestream Health, Inc. Date of Enforcement Report:2/5/2014 Class lI: PRODUCT KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608. Made in U.S.A. Recall Number Z-0844-2014 REASON Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to...Read More

http://www.ibm.com/developerworks/library/j-fuzztest/index.htmlRead More

SoftwareCPR comments on common confusion: Struggling with Essential Requirements? Many manufacturers faced with compliance to the 3rd edition of 60601-1 do not understand which of their product requirements meet the essential requirements definition. Confusion arises over the actual risk control measures designed into the system and the requirements for the “performance of a clinical function...Read More

The link provided is to an article on Fuzz testing. This type of testing involves injecting bad data to challenge your applications and safeguards. This type of testing can be important to verify risk control measures and data integrity checks are verified. The name Fuzz testing is a fairly recent moniker for techniques that have...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 1/29/2014 Class lI: PRODUCT Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. Recall Number Z-0800-2014 REASON An overflow flag //// is displayed in the result column for a test when the algorithm...Read More

Company: Elekta inc. Date of Enforcement Report:1/29/2014 Class lI: PRODUCT XiO RTP System The XiO RTP System is 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...Read More

Company: Draeger Medical Systems, Inc. . Date of Enforcement Report:1/22/2014 Class lI: PRODUCT Draeger Infinity Acute Care System Monitoring Solution Recall Number Z-0714-2014 REASON After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 1/22/2014 Class lI: PRODUCT GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698. Recall Number Z-0725-2014 REASON There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima...Read More

Company: GE Healthcare It Date of Enforcement Report: 1/22/2014 Class lI: PRODUCT Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review,...Read More

http://wallstcheatsheet.com/stocks/more-apple-iwatch-clues-fda-meeting-and-healthbook-app.htmlRead More

/docs/FDAComputationalModelsDraftGuidance0114.pdfRead More