Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/23/2016 Class lI: PRODUCT SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different...Read More

Company: Sorin Group USA, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients. Recall Number Z-0413-2017...Read More

Company: Mevion Medical Systems, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT MEVION S250 Product Usage: Proton Radiation Therapy System Recall Number Z-0411-2017 REASON Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with...Read More

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Company:Medimaps Group Date of Enforcement Report 11/16/2016 Class lI: PRODUCT TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.. Recall Number Z-0369-2017 REASON The FRAX adjusted for TBS values are not correct when: The FRAX feature is...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report 11/16/2016 Class lI: PRODUCT Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer...Read More

Company: Spacelabs Healthcare Inc Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number Z-0332-2017 REASON The firm received reports of telemetry...Read More

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm523316.htmRead More

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Company:Hospira Inc.. Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026 Recall Number Z-0353-2017 REASON Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of...Read More

Company:Hospira Inc.. Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027 Recall Number Z-0354-2017 REASON Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 11/3/2016 Class lI: PRODUCT enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. — Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System is intended...Read More

Company: Hospira, Inc. Date of Enforcement Report 11/3/2016 Class lI: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous,...Read More

Company: Hospira, Inc. Date of Enforcement Report 11/3/2016 Class lI: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous,...Read More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 10/26/2016 Class lI: PRODUCT Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 10.262016 Class lI: PRODUCT Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 10/26/2016 Class lI: PRODUCT Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 9/14/2016 Class lI: PRODUCT CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. Recall Number Z-0118-2017 REASON Customers may...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 10/26/2016 Class lI: PRODUCT Fusion Workstation.; Indicated for the transmission and review of radiological images. Recall Number Z-0294-2017 REASON After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 10/20/2016. Voluntary: Firm Initiated...Read More

A final draft (FDIS) of “IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved. The standard will be published after final editing. This is expected around the end of the year (2016). The primary focus of this standard is on requirements for the developers of the software product. It...Read More

http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm525916.htmRead More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Radiation Therapy Treatment Planning System, Model 5.0 Recall Number Z-0079-2017 REASON For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only...Read More

Company: Medtronic Navigation Inc. Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 10/19/2016 Class lI: PRODUCT Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities Recall Number Z-0073-2017 REASON Image data for a patients image may not be...Read More

Company: Elekta, Inc. Date of Enforcement Report 10/19/2016 Class lI: PRODUCT Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients...Read More

Company: Toshiba America Medical Systems, Inc Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner Recall Number Z-0048-2017 REASON It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report 10/12/2016 Class lI: PRODUCT RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) — Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of...Read More

Company: Toshiba America Medical Systems, Inc Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Toshiba America Medical Systems, Inc. Aquilion Lightning TSX-035A CT Scanner. Recall Number Z-0046-2017 REASON It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning...Read More

Company: Toshiba America Medical Systems, Inc Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Toshiba America Medical Systems, Inc . Aquilion RXL TSX-1 01 AIR, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head. Recall Number Z-0047-2017 REASON It has been found...Read More

Company: Toshiba America Medical Systems, Inc Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Toshiba America Medical Systems, Inc . Celesteion PCA-9000rV2 CT Scanner Recall Number Z-0049-2017 REASON It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Recall Number Z-2876-2016 REASON Software patch installation to address several...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Syngo.plaza VB10A, Picture Archiving and Communication System Recall Number Z-2892-2016 REASON Software upgrade to eliminate several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 9/27/2016 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 47 systems...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment...Read More

Company: Medtronic Inc. Date of Enforcement Report 10/5/2016 Class lI: PRODUCT CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Syngo.plaza, Picture Archiving and Communication System. Recall Number Z-2891-2016 REASON Software upgrade to eliminate several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 9/27/2016 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 47 systems DISTRIBUTION...Read More

Company: Spacelabs Helathcare Inc. Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. Recall Number Z-2886-2016 REASON The firm received multiple reports of Xhibit Telemetry System going offline or...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT RTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Recall Number Z-2877-2016 REASON Software patch installation to address several...Read More

Company: CareFusion 303 Inc.Date of Enforcement Report 10/52016 Class lI: PRODUCT Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can...Read More

Company: Spacelabs Helathcare Inc. Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Spacelabs Healthcare Xhibit Central Station, Model 96102. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. Recall Number Z-2885-2016 REASON The firm received multiple reports of Xhibit Telemetry System going offline or locking...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 9/28/2016 Class lI: PRODUCT Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Recall Number Z-2853-2016 REASON Software error. Incorrect values for the volume calculation from a freehand VOI...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 9/28/2016 Class lI: PRODUCT CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. Recall Number Z-2871-2016 REASON An incorrect...Read More

Company:Invivo Corporation Date of Enforcement Report 9/28/2016 Class lI: PRODUCT Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.. Recall Number Z-2790-2016 REASON Frozen...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 9/28/2016 Class lI: PRODUCT Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images Recall Number Z-2852-2016 REASON Software error. Incorrect values for the volume calculation from a freehand VOI at...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395 Recall Number Z-2803-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Recall Number Z-2798-2016 REASON There is a potential for the first and/or last name of one patient to be...Read More

Company: Thermo Finnigan LLC. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Endura MR Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306 Recall Number Z-2799-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a...Read More

Company: Hospira Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.. Recall Number Z-2790-2016 REASON...Read More