Company: on Beam Applications S.A.Date of Enforcement Report 12/31/2014 Class lI: PRODUCT adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device....Read More

Company: Bausch & Lomb Incorporated Rochester, NY Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY Recall Number Z-0862-2015 REASON A software anomaly was identified where the system may automatically transition from “Standby” to “Ready to Fire”...Read More

Company: Bausch & Lomb Incorporated Rochester, NY Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal...Read More

Company:Horiba Instruments Inc.Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX...Read More

Company: Bausch & Lomb Incorporated Rochester, NY Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal...Read More

Company: GE Healthcare It. Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have...Read More

Company: Illumina Inc.Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries....Read More

Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging. Recall Number Z-0816-2015...Read More

Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging. Recall Number Z-0817-2015...Read More

Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products. Recall Number Z-0815-2015 REASON When using the...Read More

Company: Carestream Health, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. Recall Number Z-0820-2015 REASON Reduced mammographic image quality when attempting to print true size multi-format images RECALLING FIRM/MANUFACTURER Carestream Health, Inc., Rochester, NY on...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d)...Read More

Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. Recall Number Z-0818-2015 REASON When using the...Read More

Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0. Recall Number Z-0821-2015 REASON Software Anomaly; Because of a software bug, the VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with...Read More

Company: TomoTherapy Incorporated. Date of Enforcement Report 12/17/2014 Class lI: PRODUCT TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) Recall Number Z-0507-2015 REASON Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw...Read More

Company: Mevion Medical Systems, Inc.. Date of Enforcement Report 12/17/2014 Class lI: PRODUCT MEVION S250, used for proton radiation therapy. Recall Number Z-0588-2015 REASON Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect...Read More

Company: INO Therapeutics (dba Ikaria). Date of Enforcement Report 12/17/2014 Class lI: PRODUCT INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 12/17/2014 Class lI: PRODUCT Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Recall Number Z-0576-2015 REASON Printouts may be printed in incorrect...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 12/10/2014 Class lI: PRODUCT The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. Recall Number Z-0486-2015 REASON There is a potential issue on running Artis systems running software VC1x software...Read More

Company: Abbott Molecular. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT Abbott m2000sp is intended use as an automated system for performing sample preparation for nucleic acid testing. Recall Number Z-0463-2015 REASON Abbott Molecular identified some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This may cause...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454 Recall Number Z-0450-2015 REASON Software issues RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH 11/4/2014. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company:Vision Rt Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. Recall Number Z-0464-2015 REASON Potential failure of AlignRT to assert interlock....Read More

Company: Toshiba American Medical Systems Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 Recall Number Z-0473-2015 REASON Software defect RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH 11/9/2014. Voluntary:...Read More

Company: Elekta, Inc.. Date of Enforcement Report 11/26/2014 Class lI: PRODUCT MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-0221-2015 REASON A problem can exist...Read More

Company: Accuray Incorporated Date of Enforcement Report 11/26/2014 Class lI: PRODUCT CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-0218-2015...Read More

Company: Respironics California Inc. (a division of Philips Healthcare) Date of Enforcement Report 11/19/2014 Class I: Date Recall Initiated: September 17, 2014 PRODUCT Esprit V1000 and V200 Ventilators, Model V1000 and V200, Installed with 3rd Generation Power Supplies, and 3rd Generation Power Supply Repair Part Kits ? See complete listing of serial numbers. Manufactured and...Read More

Company:Maquet Cardiovascular Us Sales, Llc. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures....Read More

Company: Integra LifeSciences Corp. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 Recall Number Z-0201-2015 REASON ntegra LifeSciences Corporation received 2 complaints that...Read More

Company: Smiths Medical ASD, Inc. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump,...Read More

Company: Iba Dosimetry Gmbh. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological. Recall Number Z-0168-2015 REASON Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over...Read More

Company: Beckman Coulter Inc.. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body...Read More

Company: Nellcor Puritan Bennett Inc. (dba Covidien LP). Date of Enforcement Report 11/6/2014 Class I: PRODUCT Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations. Recall Number Z-0112-2015 REASON A software issue may lead...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 11/6/2014 Class lI: PRODUCT Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 10/29/2014 Class lI: PRODUCT Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: ” Monitoring the physiological parameters of pregnant women ” Non-invasive monitoring of fetal heart rates and movements. Recall Number Z-0105-2015 REASON Philips Intellivue...Read More

Company:Mindray DS USA, Inc. dba Mindray North America.Date of Enforcement Report: 10/29/2014 Class lI: PRODUCT Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 10/29/2014 Class lI: PRODUCT Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 10/22/2014 Class lI: PRODUCT VITROS 5600 Integrated System, System Product Code 6802413. 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 and VITROS Immunodiagnostic Products Reagents. Recall Number Z-0078-2015 REASON...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 10/22/2014 Class lI: PRODUCT VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate,...Read More

Company:Merge Healthcare, Inc.Date of Enforcement Report: 10/22/2014 Class lI: PRODUCT eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418469.pdfRead More

Company: GE Healthcare Date of Enforcement Report: 10/15/2014 Class lI: PRODUCT GE Healthcare Carescape Patient Data Module Recall Number Z-0060-2015 REASON GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM...Read More

Company: Mckesson Information Solutions LLC.Date of Enforcement Report:10/15/2014 Class lI: PRODUCT McKesson Cardiology” Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. Recall Number Z-0042-2015 REASON Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula...Read More

Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are 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. This device may include signal analysis and...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and...Read More

Company: Siemens Healthcare DiagnosticsDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based...Read More

Company: Siemens Healthcare DiagnosticsDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be...Read More