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

Company: Hospira Inc Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT ) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with...Read More

Company: GE Healthcare, LLC Date of Enforcement Report:11/20/2013 Class ll: PRODUCT AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems....Read More

Company:Philips Healthcare Informatics, Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare...Read More

Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 Recall Number Z-0281-2014 REASON Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a...Read More

Company: Carestream Health Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and...Read More

Company:Nobel Biocare Usa Llc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery,...Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Siemens syngo.plaza image processing system image processing radiological system Recall Number Z-0271-2014 REASON The firm became aware of an unintended behavior when using the syngo.plaza. The “Rename” functionality can cause an unintended patient merge if the patient is sent to another...Read More

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Company: Carestream Health Inc. Date of Enforcement Report: 11/13/2013 Class lI: PRODUCT DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients Recall Number Z-0179-2014 REASON Carestream Health Inc. has conducted a voluntary...Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report: 11/13/2013 Class lI: PRODUCT Siemens RAD Fluoro Uro Systems – Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems Recall Number Z-0016-2014 REASON Siemens has discovered through product monitoring a potential malfunction when using system operating with software...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 11/13/2013 Class lI: PRODUCT COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of...Read More

IEC 80002-1 “Guidance on the application of ISO 14971 to medical device software” has been reconfirmed with a new stability date of 2016. This means that the document will not change before 2016. The next review to determine if the technical report should be revised will occur in 2015. IEC 80001-1 “Application of risk management...Read More

Company: GE Healthcare It Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed...Read More

Company: Ortho Clinical Diagnostics Inc Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT Ortho Verseia Pipetter (VERSEIA) Recall Number B-2518-13 REASON ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results. RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics Inc, Raritan, NJ on 8/21/2013. Voluntary:...Read More

Company: One Lambda Inc. Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR Recall Number B-2326-13 REASON HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed. RECALLING FIRM/MANUFACTURER One Lambda Inc., Canoga Park, CA...Read More

Company: Carestream Health, Inc. Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 — Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all...Read More

Company: GE Healthcare It Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT 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 is also intended for use as a clinical review workstation throughout the healthcare...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT ngenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The...Read More

FDA’s Device Center added a dedicated webpage on Cybersecurity for medical devices in its connected health section.Read More

Company: AGFA Corp. Date of Enforcement Report: 10/30/2013 Class ll: PRODUCT IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). Recall Number Z-0035-2014 REASON System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. RECALLING...Read More

Company:Siemens Medical Solutions USA, Inc.. Date of Enforcement Report: 10/30/2013 Class ll: PRODUCT Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the...Read More

Company: GE Healthcare It Date of Enforcement Report: 10/30/2013 Class lI: PRODUCT Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various...Read More

Company: Bio-Rad Laboratories Date of Enforcement Report: 10/30/2013 Class lIl: PRODUCT FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. Recall Number Z-0032-2014 REASON The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data...Read More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htmRead More

Oct 22, 2013 press release from the office of Conressman Marsha Blackburn:”Congressman Marsha Blackburn (R-TN07) joined Representatives Gene Green (D-TX29), Dr. Phil Gingrey (R-GA11), Diana DeGette (D-CO01), Greg Walden (R-OR02), and G. K. Butterfield (D-NC01) today in introducing the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act to provide regulatory clarity regarding mobile...Read More

The amendments to ISO 62366 and IEC 60601-1-6 were approved unanimously. The amendment to 62366 introduces requirements for legacy products that were created prior to the adoption of ISO 62366 and the amendment to 60601-1-6 clarifies the elements of the usability engineering process that are required for compliance with the IEC 60601 seriesRead More

This SoftwareCPR.com newsletter lists items added to the website from 7/22/2013 to 10/24/2013. It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and the related web page should...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2013 Class l: PRODUCT GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. Recall Number Z-0009-2014 REASON GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2013 Class ll: PRODUCT GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.Recall Number Z-0023-2014 REASON GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your...Read More

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

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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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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