Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/62016 Class lI: PRODUCT Product Usage: The Ingenuity Core scanner 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 taken at different angles and planes. Recall Number Z-2117-2016 REASON Philips Healthcare received...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 7/6/2016 Class lI: PRODUCT Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers – 10863171, 10863172, 10863173, Recall Number Z-2088-2016 REASON Software error in previous software versions in which two references for the same image may exist in the database. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2021-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2024-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2006-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.. Recall Number Z-2026-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2037-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 64 – 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2013-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2027-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2008-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2029-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2017-2016 REASON...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 40 – 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2007-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2031-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2018-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2010-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2032-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2023-2016 REASON Siemens Medical...Read More

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

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2012-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.. Recall Number Z-2034-2016 REASON Siemens Medical Solutions,...Read More

Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System)...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2022-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.. Recall Number Z-2035-2016 REASON...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT S(20) – 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2028-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information… Recall Number Z-2036-2016 REASON...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.. Recall Number Z-2030-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2033-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2014-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information., Recall Number Z-2005-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2015-2016 REASON Siemens Medical...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: 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

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: 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: 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