Company: Leica Biosystems Richmond Inc. Date of Enforcement Report 6/29/2016 Class lI: PRODUCT CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist...Read More

This agreement includes a number of clarifications to the EU Medical Device Regulations.  The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement on June 15.  The text of the draft MDR is at the link provided.  The text...Read More

See the item on the MDR Trilogue Agreement for further explanation.  The text for the IVD draft is a the link provided here: EU IVDR.Read More

Company: Physio-Control, Inc. Date of Enforcement Report 6/22/2016 Class lI: PRODUCT LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the...Read More

Company: Leica Biosystems Richmond Inc. Date of Enforcement Report 6/22/2016 Class lI: PRODUCT Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and...Read More

The purpose of DTSec is to establish a standard used to provide a high level of assurance that electronic products for the treatment of diabetes deliver the security protections claimed by their developers and required by their users. Diabetes Tech Society StandardRead More

/docs/scpred/standardsnavigator/EU_Data_Protection_Regulation.pdfRead More

Company: Sedecal USA, Inc.Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Sedecal SA Mobile Diagnost w DR x-ray system. Recall Number Z-1691-2016 REASON Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type ” Newborn”...Read More

Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Recall Number Z-1717-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 6/15/2016 Class lI: PRODUCT VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.. Recall Number Z-1914-2016 REASON Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600...Read More

Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Recall Number Z-1714-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...Read More

Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Recall Number Z-1719-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...Read More

Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare DigitalDiagnost stationary X-ray system. Recall Number Z-1695-2016 REASON The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. RECALLING FIRM/MANUFACTURER Philips Healthcare, Andover, MA on 11/10/2015. Voluntary: Firm...Read More

Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare DuraDiagnost stationary X-ray system. Recall Number Z-1696-2016 REASON The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. RECALLING FIRM/MANUFACTURER Philips Healthcare, Andover, MA on 11/10/2015. Voluntary: Firm...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 6/15/2016 Class lI: PRODUCT VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Recall Number Z-1913-2016 REASON Ortho Clinical Diagnostics confirmed a software timing anomaly in which...Read More

Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Recall Number Z-1716-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...Read More

Company: Brainlab AG Date of Enforcement Report 6/15/2016 Class lI: PRODUCT ExacTrac Vero is a Patient Positioning System for Radiation therapy. Recall Number Z-1729-2016 REASON Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 RECALLING FIRM/MANUFACTURER Brainlab AG, Feldkirchen, Germany on 5/4/2016. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT...Read More

Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Recall Number Z-171Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3)...Read More

Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Recall Number Z-1713-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...Read More

Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Recall Number Z-1718-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...Read More

/docs/scpred/SoftwareCPR-Newsletter052016.pdfRead More

/docs/scpred/SoftwareCPR-LatestNewsletter.htmRead More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/8/2016 Class lI: PRODUCT Ingenuity Core Computed Tomograph X-ray Systems, Product Usage: 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-1873-2016 REASON The firm became aware of a problem where the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/8/2016 Class lI: PRODUCT Brilliance 64 Computed Tomography X-ray Systems Product Usage: 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-1872-2016 REASON The firm became aware of a problem where the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/8/2016 Class lI: PRODUCT Ingenuity Computed Tomography X-ray Systems, Product Usage: 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-1875-2016 REASON The firm became aware of a problem where the system...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/8/2016 Class lI: PRODUCT Ingenuity Core 128 Computed Tomography X-ray Systems, Product Usage: 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-1874-2016 REASON The firm became aware of a problem where...Read More

Company: Siemens Healthcare Diagnostics Inc. Date of Enforcement Report 6/1/2016 Class lI: PRODUCT Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such...Read More

Company: Siemens Healthcare Diagnostics Inc. Date of Enforcement Report 6/1/2016 Class lI: PRODUCT Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such...Read More

Company: GE Medical Systems, LLC Date of Enforcement Report 6/1/2016 Class lI: PRODUCT GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.. Recall Number Z-1706-2016 REASON Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time...Read More

Company: Elekta Inc. Date of Enforcement Report 6/1/2016 Class lI: PRODUCT iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment. Recall Number Z-1705-2016 REASON If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to...Read More

Company: GE Medical Systems, LLC Date of Enforcement Report 6/1/2016 Class lI: PRODUCT GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.. Recall Number Z-1707-2016 REASON Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report 6/1/2016 Class lI: PRODUCT RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy. Recall Number Z-1712-2016 REASON A software issue with editing tools that use the left mouse button held down, for drawing in...Read More

Company:Volcano Corporation Date of Enforcement Report 6/1/2016 Class lI: PRODUCT Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of...Read More

Zimmer Biomet Holding, Inc.Product: iAssist Knee System Date: 5/27/2016 8. Failure to submit a Report of Correction or Removal for a medical device correction or removal initiated to reduce a risk to health or to remedy a violation of the Act caused by the device, which may present a risk to health, as required by...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm504091.pdfRead More

Company: Neusoft Medical Systems Co., Ltd. Date of Enforcement Report 5/18/2016 Class lI: PRODUCT NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) Recall Number Z-1650-2016 REASON It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of...Read More

The US FDA issued a draft guidance entitled: “Use of Electronic Health Record Data in Clinical Investigations”. This draft addresses a variety of issues including EHRs certified by ONC, data modifications, audit trials, informed consent, and Privacy and Security. The full draft guidance can be found at the following link: FDA_Use_of_EHR_Data_in_Clinical_InvestigationsRead More

Company: Novarad Corporation Date of Enforcement Report 5/18/2016 Class lI: PRODUCT NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation Recall Number Z-1613-2016 REASON IThe SUV values that are being calculated in the PET/CT fusion tool are incorrect. RECALLING FIRM/MANUFACTURER Novarad Corporation, American fork, UT on 11/16/2015. Voluntary: Firm Initiated recall is ongoing....Read More

Company: Acusom US Inc. Date of Enforcement Report 5/18/2016 Class lI: PRODUCT Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0). Recall Number Z-1638-2016 REASON Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a...Read More

Company: Medtronic Date of Enforcement Report 5/18/2016 Class lI: PRODUCT Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.. Recall Number Z-1648-2016 REASON Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm RECALLING FIRM/MANUFACTURER Medtronic, North Haven, CT on 4/1/2016....Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM268141.pdfRead More

Company: Carestream Health, Inc. Date of Enforcement Report 5/11/2016 Class lI: PRODUCT CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 — Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY...Read More

Company: Carestream Health, Inc. Date of Enforcement Report 5/11/2016 Class lI: PRODUCT CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/11/2016 Class lI: PRODUCT Syngo Dynamics; Kinetdx Picture Archiving and Communications System Recall Number Z-1601-2016 REASON Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result...Read More

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure .Date of Enforcement Report 5/11/2016 Class lI: PRODUCT Medtronic CareLink” Monitor (2490C) and Medtronic CareLink Express” Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network...Read More

Company: CareFusion 303 Inc..Date of Enforcement Report 5/11/2016 Class lI: PRODUCT Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.. Recall Number Z-1606-2016 REASON The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/11/2016 Class lI: PRODUCT ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816. Recall Number Z-1592-2016 REASON While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to...Read More

The US Federal Communication Commission has an initiative named Connect2HealthFCC for its exploring of the intersection of broadband, advanced technology and health and further charting the broadband future of health care – serving as an umbrella for all FCC health-oriented activities. The web page for this initiative is at the link provided. FCC works jointly...Read More

Company: Horiba Instruments Inc Date of Enforcement Report 5/4/2016 Class lI: PRODUCT Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/4/2016 Class lI: PRODUCT ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 – ACUSON X700 Ultrasound System (Russia) 10658845 – ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following...Read More