Company:Heartsine Technologies, Limited Date of Enforcement Report 11/7/12 Class ll: PRODUCT HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation. Recall...Read More

Company:Varian Medical Systems, Inc. Oncology Systems Date of Enforcement Report 11/7/12 Class ll: PRODUCT ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. Recall Number Z-0187-2013 REASON An anomaly has been identified with the ARIA Oncology Information System Version 11...Read More

Company:Elekta, Inc Date of Enforcement Report 11/7/12 Class ll: PRODUCT MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images....Read More

The first committee draft of the second edition of “IEC 62304 Medical device software life cycle processes” has been circulated internally for comment. Major changes include a revision of how software safety class is determined, which could reduce the tendency towards most software being Class C; clear requirements for legacy software that explain how conformance...Read More

Company:Orthosensor Date of Enforcement Report 10/31/12 Class ll: PRODUCT ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***” Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.Recall Number Z-0122-2013 REASON Ortho sensor in Sunrise, FL...Read More

Company:GE Healthcare LLC. Date of Enforcement Report 10/31/12 Class ll: PRODUCT GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. Recall Number Z-0125-2013 REASON GE Healthcare has recently...Read More

Company:Elekta, Inc. Date of Enforcement Report 10/31/12 Class ll: PRODUCT Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer. Recall Number Z-0118-2013 REASON During the planning process the beam weights can be changed by the customers. When the...Read More

Company: GE Healthcare, LLC Date of Enforcement Report 10/31/12 Class ll: PRODUCT GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: 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...Read More

Company:Hospira Inc. Date of Enforcement Report 10/26/12 Class l: PRODUCT Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes,...Read More

Company:Hospira Inc. Date of Enforcement Report 10/26/12 Class l: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes,...Read More

http://www.fda.gov/training/cdrhlearn/ucm162015.htmRead More

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...Read More

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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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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.Read More

Draft of the revised IVDD is at the link provided. EU Proposed New IVDRead More

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 MDDRead More

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/presentationsRead More

See the attached press release from AAMI and UL regarding their collaboration to produce a series of interoperability standards. AAMI UL Interoperability Press ReleaseRead More

/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdfRead More

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...Read More

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...Read More

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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.Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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....Read More

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...Read More

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...Read More

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...Read More

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...Read More

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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...Read More

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...Read More

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...Read More

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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,...Read More

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...Read More

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...Read More