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: 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: Roche Molecular SystemsDate of Enforcement Report 5/4/2016 Class lI: PRODUCT Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems. Recall Number Z-1578-2016 REASON The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID. RECALLING FIRM/MANUFACTURER Roche Molecular Systems, Branchburg, NJ on 3/3/2016....Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/4/2016 Class lI: PRODUCT SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission. Recall Number Z-1558-2016 REASON The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to...Read More

Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 5/4/2016 Class lI: PRODUCT Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send...Read More

Company: Philips Visicu Date of Enforcement Report 5/4/2016 Class lI: PRODUCT IeCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff. Recall Number Z-1557-2016 REASON The adherence check generates a software error. Two issues occur as a result of the software error: 1)...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

Company: Intuitive Surgical, Inc. Date of Enforcement Report 5/4/2016 Class lI: PRODUCT EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive...Read More

Company: Philips and Neusoft Medical Systems Co., Ltd. Date of Enforcement Report 5/4/2016 Class lI: PRODUCT NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. Recall Number Z-1573-2016 REASON The following issues...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/27/2016 Class lI: PRODUCT Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Recall Number Z-1519-2016 REASON Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/27/2016 Class lI: PRODUCT Siemens SOMATOM Definition Flash: Intended to produce cross-sectional images of the body. Recall Number Z-1520-2016 REASON Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/27/2016 Class lI: PRODUCT Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; : Intended to produce cross-sectional images of the body. Recall Number Z-1521-2016 REASON Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/27/2016 Class lI: PRODUCT Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Recall Number Z-1518-2016 REASON Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 4/13/2016 Class lI: PRODUCT ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories Recall Number Z-1500-2016 REASON TSoftware anomaly; Siemens identified that software version 1.4.2133 on...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Brilliance iCT:SP Computed Tomography X-ray Systems, 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-1353-2016 REASON The firm was notified of a software error in which the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Ingenuity Core Computed Tomography X-ray Systems, 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-1354-2016 REASON The firm was notified of a software error in which the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Brilliance iCT:Computed Tomography X-ray Systems, 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-1352-2016 REASON The firm was notified of a software error in which the system...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Brilliance 64:Computed Tomography X-ray Systems, 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-1351-2016 REASON The firm was notified of a software error in which the system...Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report 4/20/2016 Class lI: PRODUCT SurgiCounter” scanner Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures. Recall Number Z-1379-2016 REASON The affected SurgiCounter scanner...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Ingenuity CT Computed Tomography X-ray Systems, 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-1356-2016 REASON The firm was notified of a software error in which the...Read More

Company: Alcon Research, Ltd.Date of Enforcement Report 4/20/2016 Class lI: PRODUCT VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Ingenuity Core 128 Computed Tomography X-ray Systems, 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-1355-2016 REASON The firm was notified of a software error in which...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/13/2016 Class lI: PRODUCT A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. Recall Number Z-1349-2016 REASON To inform users about the possible incorrect values for Distance Measurements when using...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 4/6/2016 Class lI: PRODUCT MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software 10805072 LabPro MBT Non-Connect Systems v4.30 10805073...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/6/2016 Class lI: PRODUCT Cios Alpha, mobile X-ray system. Recall Number Z-1278-2016 REASON Software issues on Cios Alpha mobile C-Arm system RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/19/2016. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 89 systems DISTRIBUTION...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/6/2016 Class lI: PRODUCT Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general...Read More

Company: CareFusion 303 Inc..Date of Enforcement Report 3/30/2016 Class lI: PRODUCT Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092. Recall Number Z-1239-2016 REASON CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a “System Error” or “Missing Battery” error code (120.4630). RECALLING FIRM/MANUFACTURER CareFusion...Read More

Company: Roche Diagnostics Operations, Inc. .Date of Enforcement Report 3/30/2016 Class lI: PRODUCT cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. Recall Number Z-1233-2016 REASON Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/30/2016 Class lI: PRODUCT syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional proceduress. Recall Number Z-1232-2016 REASON After...Read More

Company: MITSUBISHI HEAVY INDUSTRIES, LTD.,.Date of Enforcement Report 3/30/2016 Class lI: PRODUCT MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated. Recall Number Z-1244-2016 REASON Due to Operator Console software anomaly, a change in treatment completion status of...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/23/2016 Class lI: PRODUCT Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading...Read More

Company: CHG Hospital Beds Inc. Date of Enforcement Report 3/23/2016 Class lI: PRODUCT The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable...Read More

Company:Roche Diagnostics Operations, Inc. Date of Enforcement Report 3/23/2016 Class lI: PRODUCT Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling...Read More

Company: Covidien LP (formerly Nellcor Puritan Bennett Inc.) Date of Enforcement Report 3/23/2016 Class lI: PRODUCT Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.. Recall Number Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide...Read More

Company: Mckesson Medical Immaging Date of Enforcement Report 3/23/2016 Class lI: PRODUCT McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1. Recall Number Z-1182-2016 REASON McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS 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; IVD. The VITROS 5.1, FS Chemistry System performs discrete clinical tests on serum, urine, and...Read More

Company: Spacelab Healthcare, Inc. Date of Enforcement Report 3/16/2016 Class lI: PRODUCT Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number Z-1092-2016 REASON The firm has received one report of values...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents...Read More

Company: Philips Respironics. Date of Enforcement Report 3/46/2016 Class lI: PRODUCT Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.. Recall Number Z-1065-2016 REASON Software issue. RECALLING FIRM/MANUFACTURER Philips...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/16/2016 Class lI: PRODUCT Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens....Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. 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: Regulatory Insight, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system. Recall Number Z-0803-2016 REASON The Firm has discovered a Software bug. RECALLING FIRM/MANUFACTURER Olympus Scientific Solutions Americas, Waltham,MA on 2/19/2016. Voluntary: Firm Initiated recall is...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm). Recall Number Z-0857-2016 REASON Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.. RECALLING FIRM/MANUFACTURER Philips Medical Systems,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/2/2016 Class lI: PRODUCT software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Philips Healthcare IntelliVue Info Center iX, A.0 866023 Recall Number Z-0856-2016 REASON Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Andover, MA on 2/23/2016. Voluntary:...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Philips IntelliVue Measurement Module X1 Model: M3001A. Recall Number Z-0853-2016 REASON The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.. Recall Number Z-0862-2016 REASON Siemens is releasing...Read More