Company:Sysmex America Inc Date of Enforcement Report:2/19/2014 Class lI: PRODUCT The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories. Recall Number Z-0949-2014 REASON The current Century...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/19/2014 Class lI: PRODUCT Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for...Read More

Company:Ortho-Clinical Diagnostics Date of Enforcement Report:2/19/2014 Class lI: PRODUCT enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation 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...Read More

Company: Bio-Rad Laboratories, Inc. Date of Enforcement Report:2/19/2014 Class lI: PRODUCT D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale}...Read More

Company:Neuro Kinetics, Inc. Date of Enforcement Report:2/19/2014 Class lI: PRODUCT Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. Recall Number Z-0966-2014 REASON The data provided on the Normative Data Template CD for use with the I-Portal devices has not...Read More

Company:Mckesson Information Solutions LLCDate of Enforcement Report:2/19/2014 Class lI: PRODUCT Horizon Medical Imaging, Picture Archive Communication System (PACS). Recall Number Z-0976-2014 REASON Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.. RECALLING FIRM/MANUFACTURER Mckesson Information Solutions LLC,...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report:2/122014 Class lI: PRODUCT Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476) Recall Number Z-0932-2014 REASON The PET Reconstruction Server (PRS)...Read More

Company: B. Braun Medical, Inc.Date of Enforcement Report:2/122014 Class lI: PRODUCT B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications. Recall Number Z-0921-2014 REASON Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion...Read More

Company: Stryker Medical Division of Stryker Corporation Date of Enforcement Report:2/122014 Class lI: PRODUCT The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 2/12/2014 Class lI: PRODUCT CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time....Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:2/12/2014 Class lI: PRODUCT Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.Recall Number Z-0907-2014 REASON During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version...Read More

Company: AGFA. Corp. Date of Enforcement Report:2/12/2014 Class lI: PRODUCT IMPAX RIS QDOC 5.8 Recall Number Z-0919-2014 REASON Patient name displayed (printed) on the Patient Report was the wrong patient name. RECALLING FIRM/MANUFACTURER AGFA. Corp., Greenville, SC. on 1/8/2014. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 14 DISTRIBUTION CA, FL, GA,...Read More

Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Centricity PACS System versions 3.X and higher and 4.X and higher_x000D_ Product Usage: 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...Read More

Company: Integra LifeSciences Corp.. Date of Enforcement Report:2/5/2014 Class lI: PRODUCT ntegra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA_x000D_ _x000D_ The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. _x000D_ _x000D_ 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-0840-2014 REASON There is an issue with the...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Siemens CentraLink” Data Management System V14.0.4, V14.0.5 or V14.0.8_x000D_ _x000D_ The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected...Read More

Company: DeRoyal Industries Inc Date of Enforcement Report:2/5/2014 Class lI: PRODUCT 1. Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China._x000D_ _x000D_ Physical Therapy. Recall Number Z-0834-2014 2. DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx...Read More

Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially...Read More

Company: Carestream Health, Inc. Date of Enforcement Report:2/5/2014 Class lI: PRODUCT KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608. Made in U.S.A. Recall Number Z-0844-2014 REASON Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to...Read More

Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems._x000D_ _x000D_ Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. Recall Number Z-0800-2014 REASON An overflow flag //// is displayed in the result column for a test when the...Read More

Company: Elekta inc. Date of Enforcement Report:1/29/2014 Class lI: PRODUCT XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 1/29/2014 Class lI: PRODUCT Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. Recall Number Z-0800-2014 REASON An overflow flag //// is displayed in the result column for a test when the algorithm...Read More

Company: Draeger Medical Systems, Inc. . Date of Enforcement Report:1/22/2014 Class lI: PRODUCT Draeger Infinity Acute Care System Monitoring Solution Recall Number Z-0714-2014 REASON After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 1/22/2014 Class lI: PRODUCT GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698. Recall Number Z-0725-2014 REASON There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima...Read More

Company: GE Healthcare It Date of Enforcement Report: 1/22/2014 Class lI: PRODUCT Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review,...Read More

Company: Carestream Health Inc. Date of Enforcement Report:1/15/2014 Class lI: PRODUCT Carestream DRX-Revolution Mobile X-Ray System — Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 — The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products...Read More

Company: EOS Imaging Date of Enforcement Report:1/15/2014 Class lI: PRODUCT EOS System X- ray beam Digital radiography system used in general radiographic examinations. Recall Number Z-0529-2014 REASON EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from...Read More

Company: Covidien. Date of Enforcement Report:1/15/2014 Class lI: PRODUCT Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014 REASON Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions...Read More

Company: Welch Allyn Protocol, Inc Date of Enforcement Report:1/15/2014 Class lI: PRODUCT The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate...Read More

Company:Covodien. Date of Enforcement Report:1/9/2014 Class l: PRODUCT Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG._x000D_ _x000D_ The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014 REASON Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop...Read More

Company: GE Healthcare It Date of Enforcement Report: 1/8/2014 Class lI: PRODUCT The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially...Read More

Company: Nipro Diganostics Date of Enforcement Report:1/6/2014 Class lI: PRODUCT TRUEbalance and TRUEtrack blood glucose meters distributed in the U.S., Europe, Asia and Canada, the company said Thursday. REASON The affected meters ? 501 TRUEbalance and 105 TRUEtrack ? may have a flaw in the factory-set unit of measure that would cause them to measure...Read More

Company: Mckesson Information Solutions LLC Date of Enforcement Report:1/1/2014 Class lI: PRODUCT McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). Recall Number Z-0556-2014 REASON When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record. RECALLING FIRM/MANUFACTURER Mckesson...Read More

Company: EOS Imaging Date of Enforcement Report:1/1/2014 Class lI: PRODUCT steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images. Recall Number Z-0580-2014 REASON Error copying information to...Read More

Company: Varian Medical Systems, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation. Recall Number Z-0552-2014 REASON An anomaly...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in...Read More

Company:CareFusion 303, Inc.. Date of Enforcement Report:1/1/2014 Class l: PRODUCT Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia)...Read More

Company: Data Innovations, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004 Recall Number Z-0571-2014 REASON When connected to the Sysmex UF-100, the...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report:12/25/2013 Class lI: PRODUCT MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report:12/25/2013 Class lI: PRODUCT Access Immunoassay Systems Reaction Vessels. The Access 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 fluids. Recall Number Z-0519-2014 REASON Beckman Coulter is initiating a recall for the...Read More

Company: Omnyx Llc Date of Enforcement Report:12/18/2013 Class lI: PRODUCT Digital Pathology System (DPS) Software version 1.1 The Omnyx” Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx” products are for...Read More

Company: SCC Soft Computer Date of Enforcement Report:12/18/2013 Class lI: PRODUCT SoftBank II versions: 23.1, 23.2, 25.0, 25.1, 25.2, and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x Recall Number B-0216-14 REASON Blood Bank software with a defect or glitch, was distributed.. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwataer, FL on 11/11//2013. Voluntary: Firm Initiated...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 12/18/2013 Class lI: PRODUCT GE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters...Read More

Company: Iba Dosimetry Gmbh Date of Enforcement Report:12/18/2013 Class lI: PRODUCT iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological Recall Number Z-0456-2014 REASON The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation....Read More

Company: Cincinnati Sub-Zero Products Inc Date of Enforcement Report:12/11/2013 Class lI: PRODUCT Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol...Read More

Company: Haemonetics Software Solutions Date of Enforcement Report:12/11/2013 Class lI: PRODUCT ElDorado Donor Doc Software, comprehensive donor health qualification computer system, run in a native Internet Explorer browser that is displayed in kiosk mode. Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0 Recall Number B-0008-14 REASON Blood Bank Software, with a defect or glitch, was...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Reloaded Vista Vials – limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids. Recall Number Z-0430-2014 REASON There is the potential...Read More

Company: GE Healthcare It Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT syngo(R) Lab Data Manager – Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help...Read More