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Company:Beckman Coulter Inc. Date of Enforcement Report 10/24/12 Class ll: PRODUCT AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic...
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Company:Beckman Coulter Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide...
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Company:Beckman Coulter Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the...
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A new version of EN 14971 was published and harmonized in the Official Journal of the EU. ISO 14971 now may not ensure compliance with EU essential requirements for medical devices. Specifically, 14971 allows the manufacturer to disregard negligible risks; but all risks must be taken into account and reduced as much as possible to...
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Company:Sunquest Information Systems, Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT Sunquest Laboratory. Sunquest Application Interfacing Outbound Department of Health Interface. Recall Number B-2584-12 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tuscon, AZ on 12/14/2009. Voluntary: Firm Initiated recall was terminated. VOLUME OF PRODUCT IN COMMERCE...
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Company:Beckman Coulter Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the...
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Presentations made at the AAMI/FDA Interoperability Summit on October 1-2, 2012, can be found at the link provided. http://www.aami.org/interoperability/presentations
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See the attached press release from AAMI and UL regarding their collaboration to produce a series of interoperability standards. AAMI UL Interoperability Press Release
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Draft of the revised IVDD is at the link provided. EU Proposed New IVD
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Draft of the revised MDD is at the link provided. The existing Active Implantable Device Directive is incorporated into the new MDD. EU Proposed New MDD
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An FCC mHealth task force reported recommendations to government and industry to address barriers to rapid mHealth deployment. See the link provided: FCC 2012 Mhealth Taskforce Recommendations.
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/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdf
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Company:Imaging Sciences International, LLC Date of Enforcement Report 9/26/12 Class ll: PRODUCT DEXIS Imaging Suite – catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System Recall Number Z-2463-2012 REASON A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature...
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Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 9/26/12 Class ll: PRODUCT SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT...
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AAMI has published “AAMI TIR45: 2012 Guidance on the use of AGILE practices in the development of medical device software.” FDA staff was involved in development of this guidance for compliant use of Agile methods. The document can be ordered from AAMI.org.
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Company:Roche Molecular Systems, Inc. Date of Enforcement Report 9/26/12 Class ll: PRODUCT Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System. Recall Number Z-2403-2012 REASON When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2...
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Company:Philips Medical Systems (Cleveland) Inc. Date of Enforcement Report 9/26/12 Class lll: PRODUCT The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.Recall...
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Company:Haag-Streit USA Inc. Date of Enforcement Report 9/26/12 Class ll: PRODUCT Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees...
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Company:SCC Soft Computer Date of Enforcement Report 9/26/12 Class ll: PRODUCT Product is SoftBank software (versions 21.4.2 to 23.0.0). Recall Number B-2337-12 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Palm Harbor, FL on 2/23/2006. Voluntary: Firm Initiated recall has been terminated. VOLUME OF PRODUCT IN COMMERCE 10 units...
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Company:Zoll Medical Corp. Date of Enforcement Report 9/26/12 Class ll: PRODUCT Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized...
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Company:Volcano Corporation Date of Enforcement Report 9/19/12 Class ll: PRODUCT Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology. Recall Number Z-2345-2012 REASON The display on the...
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Company:GE Healthcare LLC Date of Enforcement Report 9/19/12 Class ll: PRODUCT Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. Recall Number Z-2255-2012 REASON Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is...
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Company:GE Healthcare, LLC. Date of Enforcement Report 9/19/12 Class ll: PRODUCT GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures....
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Company:Micro Typing Systems Inc. Date of Enforcement Report 9/19/12 Class ll: PRODUCT ORTHO-ProVue (TM) A modular, microprocessor-controled instrument.B-2373-12 REASON ORTHO ProVue, with a software glitch or defect that could lead to erroneuous results, was distributed. RECALLING FIRM/MANUFACTURER Capintec Inc., Pompano Beach FL on 7/8/2004. Voluntary: Firm Initiated recall has been terminated. VOLUME OF PRODUCT IN...
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Company:Sunquest Information Systems, Inc. Date of Enforcement Report 9/19/12 Class ll: PRODUCT Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow...
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http://www.aami.org/meetings/courses/trainer.details.html
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Company:Capintec Inc. Date of Enforcement Report 9/12/12 Class ll: PRODUCT Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity. Recall Number Z-2312-2012 REASON Customers who received a Capintec Captus 3000...
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Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 9/12/12 Class ll: PRODUCT Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters...
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http://lms.ulknowledgeservices.com/catalog/display.resource.aspx?resourceid=411809
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Company:Trek Diagnostic Systems Date of Enforcement Report 9/12/12 Class lll: PRODUCT VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and...
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Company:Sendx Medical Inc Date of Enforcement Report 9/5/12 Class ll: PRODUCT ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) – pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases,...
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Company:Cisco Systems Date of Enforcement Report 9/5/12 Class ll: PRODUCT Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a...
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Company:Toshiba American Medical Systems Inc. Date of Enforcement Report 9/5/12 Class ll: PRODUCT EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy. Z-2278-2012 REASON The status display in the...
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Company:Toshiba American Medical Systems Inc. Date of Enforcement Report 9/5/12 Class ll: PRODUCT Whole Body X–ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation. Z-2282-2012 REASON 1. It has been found that in raw data processing for...
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Company:Mindray DS USA, Inc. d.b.a. Mindray North America Date of Enforcement Report 9/5/12 Class ll: PRODUCT V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the...
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Company:I-Flow Corporation Date of Enforcement Report 8/31/12 Class l: PRODUCT ON-Q Pump with ONDEMAND Bolus Button. The I-Flow ON-Q pump with ONDEMAND bolus button was manufactured from October 18, 2002 through April 30, 2012 and distributed from May 3, 2010 through May 1, 2012 Use: The On-Q pump with ONDEMAND bolus button is used for...
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Company:AGFA Corp. . Date of Enforcement Report 8/29/12 Class ll: PRODUCT AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device .Recall Number Z-2252-2012 REASON Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa’s Medical...
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Company:Baxter Healthcare Corp. Date of Enforcement Report 8/29/12 Class l: PRODUCT Product Name Product Codes Serial Numbers Automix High Speed Compounder System 2M8077 All Automix Plus High Speed Compounder System 2M8075 All Automix 3+3 Compounder System 2M8286 and 2M8286K All Automix 3+3 Compounder System with Accusource Monitoring System 2M8287 All Range of Manufacturing and Distribution...
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Company:achi Medical Systems America Inc Date of Enforcement Report 8/29/12 Class ll: PRODUCT Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination. Z-2254-2012 REASON...
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Company:Sunquest Information Systems, Inc. Date of Enforcement Report 8/29/12 Class lll: PRODUCT Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. Recall Number Z-2243-2012 REASON Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than...
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Company: Beckman Coulter Inc. Date of Enforcement Report 8/29/12 Class ll: PRODUCT UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination...
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Company:GE Healthcare, LLC Date of Enforcement Report 8/22/12 Class ll: PRODUCT GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced...
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Company:AGFA Corp. . Date of Enforcement Report 8/22/12 Class ll: PRODUCT IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) All software versions. Recall Number Z-2184-2012 REASON Content entered into the “Conclusions” free text box on the Report Writer screen was not represented...
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FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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