Company: One Lambda Inc. Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR Recall Number B-2326-13 REASON HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed. RECALLING FIRM/MANUFACTURER One Lambda Inc., Canoga Park, CA...Read More

Company: GE Healthcare It Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT ngenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The...Read More

Company: Ortho Clinical Diagnostics Inc Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT Ortho Verseia Pipetter (VERSEIA) Recall Number B-2518-13 REASON ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results. RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics Inc, Raritan, NJ on 8/21/2013. Voluntary:...Read More

Company: GE Healthcare It Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed...Read More

Company: Carestream Health, Inc. Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 — Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all...Read More

Company: AGFA Corp. Date of Enforcement Report: 10/30/2013 Class ll: PRODUCT IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). Recall Number Z-0035-2014 REASON System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. RECALLING...Read More

Company: GE Healthcare It Date of Enforcement Report: 10/30/2013 Class lI: PRODUCT Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various...Read More

Company: Bio-Rad Laboratories Date of Enforcement Report: 10/30/2013 Class lIl: PRODUCT FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. Recall Number Z-0032-2014 REASON The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data...Read More

Company:Siemens Medical Solutions USA, Inc.. Date of Enforcement Report: 10/30/2013 Class ll: PRODUCT Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2013 Class ll: PRODUCT GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.Recall Number Z-0023-2014 REASON GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2013 Class l: PRODUCT GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. Recall Number Z-0009-2014 REASON GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2013 Class ll: PRODUCT GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging. Recall Number Z-0024-2014 REASON GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved...Read More

Company: Mckesson Information Solutions LLC Date of Enforcement Report: 10/9/2013 Class ll: PRODUCT McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information...Read More

Company:Hologic Inc. Date of Enforcement Report: 10/9/2013 Class ll: PRODUCT Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use...Read More

Company: Codman & Shurtleff, Inc. Date of Enforcement Report: 10/2/2013 Class l: PRODUCT MedStream Programmable Pump; 20ml – 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for...Read More

Company: Elekta Inc. Date of Enforcement Report: 10/2/2013 Class ll: PRODUCT Monaco RTP System Radiation treatment planning Recall Number Z-2276-2013 REASON Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values. RECALLING FIRM/MANUFACTURER Elekta, Inc, Atlanta, GA on 7/2/2013. Voluntary: Firm Initiated recall is...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/2/2013 Class ll: PRODUCT GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T....Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. Recall Number Z-2241-2013 REASON GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed. RECALLING FIRM/MANUFACTURER GE Healthcare,...Read More

Company: B Braun Medical, Inc. Date of Enforcement Report: 9/25/2013 Class l: PRODUCT Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and...Read More

Company: B Braun Medical, Inc. Date of Enforcement Report: 9/18/2013 Class lI: PRODUCT Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative...Read More

Company: Data Innovations. Date of Enforcement Report: 9/11/2013 Class ll: PRODUCT 1. Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002 Recall Number B-2265-13 2. Data Innovations Instrument Manager software Model – Versions 8.12.01 Recall Number B-2299-13 REASON Laboratory software, with a defect...Read More

Company: Nidek Inc. Date of Enforcement Report: 9/11/2013 Class llI: PRODUCT WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes. Recall Number Z-2131-2013 REASON The recall of the WASP (Walk Away...Read More

Company: GE Healthcare, LLC Date of Enforcement Report:9/4/2013 Class ll: PRODUCT GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports...Read More

Company: MCKESSON TECHNOLOGIES INC. Date of Enforcement Report: 9/4/2013 Class ll: PRODUCT Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures. Recall Number Z-2089-2013 REASON The firm issued a clinical alert after users reported an...Read More

Company: Nidek Inc. Date of Enforcement Report: 9/4/2013 Class ll: PRODUCT NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. Recall Number Z-2046-2013 REASON Under certain circumstances, the Left eye image may be saved as the Right eye...Read More

Company:Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 9/4/2013 Class ll: PRODUCT Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures. Recall Number Z-1956-2013 REASON Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on...Read More

Company: Veridex, LLC Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT 1. CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as...Read More

Company: Carestream Health Inc. Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT Carestream DRX Evolution System, X-ray system — The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Recall Number Z-1877-2013 REASON To a potential for an x-ray exposure technique change. RECALLING FIRM/MANUFACTURER Carestream...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology...Read More

Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK Date of Enforcement Report: 8/14/2013 Class ll: PRODUCT MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in...Read More

Company: bioMerieux Inc. Date of Enforcement Report: 8/14/2013 Class ll: PRODUCT bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial...Read More

Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit Company: Iradimed Corporation Date of Enforcement Report: 8/12/13 Date Recall Initiated: 7/1/2013 Class l: PRODUCT MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium...Read More

Company:Picis Inc. Date of Enforcement Report:8/7/2013 Class ll: PRODUCT Picis ED Pulsecheck – EMR Software Application – 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes. Recall Number Z-1814-2013 REASON Notes...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/7/2013 Class ll: PRODUCT GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid...Read More

Company: Hospira Inc. Date of Enforcement Report: 8/7/2013 Class ll: PRODUCT The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. Recall Number Z-1847-2013 REASON The devices secondary audio signal fails to...Read More

Company:Beckman Coulter Inc. Date of Enforcement Report: 8/7/2013 Class ll: PRODUCT AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only. Recall Number Z-1834-2013 REASON The recall was initiated because Beckman Coulter has identified a software error on...Read More

Company:Topcon Medical Laser Systems, Inc Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient’s eye. Recall Number Z-1774-2013 REASON When using the “Favorites” function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system. Recall Number Z-1782-2013 REASON Siemens issued a customer safety advisory notice and field safety corrective action for...Read More

Company: Del Mar Reynolds Medical, Ltd. Date of Enforcement Report: 7/31/2013 Class lI: PRODUCT Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used...Read More

Company:Blood Bank Computer Systems, Inc. Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT Blood Bank software Primary Application with Model numbers 5.4.0.2 and 5.4.1. Recall Number B-2148-13 REASON Blood Bank software Primary Application (Model Numbers 5.4.0.2 and 5.4.1), with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc., Auburn, WA on...Read More

Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report: 7/24/2013 Class ll: PRODUCT CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired....Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report: 7/24/2013 Class ll: PRODUCT RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of...Read More

Company: Technidata S.A. Date of Enforcement Report: 7/24/2013 Class llI: PRODUCT TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S) Recall Number Z-1743-2013 REASON A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other...Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report: 7/24/2013 Class ll: PRODUCT Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such...Read More