Company: Varian Medical Systems Date of Enforcement Report 7/20/2016 Class lI: PRODUCT Optical Surface Monitoring System{Align RT Plus} This is used on Varian’s TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.. Recall...Read More

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure .Date of Enforcement Report 7/13/2016 Class lI: PRODUCT Medtronic, MyCareLink” Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician. Recall Number Z-2125-2016...Read More

Company: ZYTO Technologies Inc. Date of Enforcement Report 7/13/2016 Class lI: PRODUCT The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline). Recall...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 7/13/2016 Class lI: PRODUCT VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through...Read More

Company: ZYTO Technologies Inc. Date of Enforcement Report 7/13/2016 Class lI: PRODUCT The ZYTO Tower is the input device to program the software with various virtual items. Recall Number Z-2120-2016 REASON ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance....Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 7/6/2016 Class lI: PRODUCT SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets., Recall Number Z-2107-2016 REASON Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior:...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/62016 Class lI: PRODUCT Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 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…...Read More

Company: CareFusion 303 Inc.Date of Enforcement Report 7/6/2016 Class lI: PRODUCT Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System. Recall Number Z-2064-2016 REASON A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/62016 Class lI: PRODUCT Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 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...Read More

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 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 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, 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-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 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 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 – 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 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 40-3R 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 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: 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: 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: 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: 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 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 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 64-3R 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 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: 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