Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications...Read More

Company: Bio-Rad Laboratories Inc.Date of Enforcement Report 2/3/2016 Class lI: PRODUCT D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 1/20/2016 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 1/20/2016 Class lI: PRODUCT VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 1/20/2016 Class lI: PRODUCT VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 1/20/2016 Class lI: PRODUCT VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Oncentra External Beam – VMAT – Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-0604-2016 REASON When...Read More

Company: Philips Ultrasound Inc Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0) Recall Number Z-0596-2016 REASON Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or...Read More

Company:Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Date of Enforcement Report 1/132016 Class lI: PRODUCT Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. Recall Number Z-0597-2016 REASON Potential post-processing software issue when using tabcard “4D” on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are...Read More

Company: Vidco Inc.Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/6/2016 Class lI: PRODUCT MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-0557-2016 REASON Incorrect drug dosage...Read More

Company: Merge Healthcare Inc. Date of Enforcement Report 1/6/2016 Class lI: PRODUCT Merge Cardio with software version 10.1 LA. Recall Number Z-0555-20166 REASON The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. RECALLING FIRM/MANUFACTURER Merge Healthcare Inc., Hartland, WI...Read More

Company: Merge Healthcare Inc. Date of Enforcement Report 1/6/2016 Class lI: PRODUCT Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. Recall Number Z-0554-2016 REASON The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity Core 128 Computed Tomography X-ray system Recall Number Z-0548-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance iCT Computed Tomography X-ray system Recall Number Z-0545-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity Core Computed Tomography X-ray system Recall Number Z-0547-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance 64 Computed Tomography X-ray system Recall Number Z-0544-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Syngo Imaging XS is a Picture Archiving and Communication System (PACS) Recall Number Z-0550-2016 REASON For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction...Read More

Company: Draeger Medical, Inc. Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients. Recall Number Z-0436-2016 REASON The firm became aware of cases in which the battery...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance iCT SP Computed Tomography X-ray system Recall Number Z-0546-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity CT Computed Tomography X-ray system Recall Number Z-0549-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Shimadzu Medical Systems.Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Mobile X-ray system MobileDaRt Evolution/FDR Go Software Recall Number Z-0451-2016 REASON Shimadzu Corporation is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly… RECALLING FIRM/MANUFACTURER Shimadzu Medical Systems, Torrence, CA on 11/10/2015. Voluntary: Firm Initiated recall is...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Brilliance 64 Computed Tomography X-ray system Recall Number Z-0405-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Ingenuity CT Computed Tomography X-ray system Recall Number Z-0408-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: Beckman Coulter Inc..Date of Enforcement Report 12/23/2015 Class lI: PRODUCT UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is...Read More

Company: Beckman Coulter Inc..Date of Enforcement Report 12/23/2015 Class lI: PRODUCT UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as...Read More

Company: GE Medical Systems, LLC.Date of Enforcement Report 12/23/2015 Class lI: PRODUCT GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table,...Read More

Company: GE Medical Systems, LLC.Date of Enforcement Report 12/23/2015 Class lI: PRODUCT GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Brilliance 64 Computed Tomography X-ray system Recall Number Z-0407-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Ingenuity Core Computed Tomography X-ray system Recall Number Z-0406-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: Beckman Coulter Inc..Date of Enforcement Report 12/23/2015 Class lI: PRODUCT UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is...Read More

Company:.Visicu, Inc.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an...Read More

Company: Philips Medical System12/1610/28Class lI: PRODUCT Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart...Read More

Company: GE Medical Systems, LLC.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the...Read More

Company:.WalkMed Infusion, LLC.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT WalkMed Infusion Triton Infusion Pump (model 300000). Packaged in a single pump box. Four pump boxes are place in an over-shipper for distribution. Recall Number Z-0369-2016 REASON WalkMed Infusion is conducting a field action on the Triton Infusion Pumps (model numbers 300000 and 400000) because...Read More

Company:.Carl Zeiss Meditec AG.Date of Enforcement Report 12/9/2015 Class lI: PRODUCT IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. Recall Number Z-0357-2016 REASON IOL Master software versions 7.5 and 7.7 calculation printouts and exported...Read More

Company:.Carl Zeiss Meditec AG.Date of Enforcement Report 12/9/2015 Class lI: PRODUCT IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. Recall Number Z-0325-2016 REASON When a fused series of a sagittal, coronal or radial multi station scan is generated...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 Recall Number Z-0326-2016 REASON Ultrafiltration (UF) Volume software error inaccurate fluid removal RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 323...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A Recall Number Z-0327-2016 REASON Ultrafiltration (UF) Volume software error inaccurate fluid removal RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 16...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler – Model no. NX1000-3. For home hemodialysis. Recall Number Z-0335-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler – Model no. NX1000-3-A. For home hemodialysis. Recall Number Z-0336-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4. Recall Number Z-0337-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...Read More

Company:Philips Electronics North America Corporation.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation. Recall Number Z-0320-2016 REASON The following MRx software issue has been identified: MRx model M3535A with software version F.03.06...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Syngo Imaging VB36D_HF02. Radiological image processing system. Recall Number Z-0319-2016 REASON To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. RECALLING FIRM/MANUFACTURER...Read More

Company: AGFA Healthcare Corp.Date of Enforcement Report 11/25/2015 Class lI: PRODUCT IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed. Recall Number Z-0283-2016 REASON Customers have experienced IMPAX CV...Read More

Company: Brainlab AG Date of Enforcement Report 11/25/2015 Class lI: PRODUCT BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery. Recall Number Z-0282-2016 REASON nstances of data sets not being accurately...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging...Read More