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: 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: 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: 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: 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: 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: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: 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: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: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: 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

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: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 7/10/2013 Class ll: PRODUCT Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 7/3/2013 Class ll: PRODUCT Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission. Recall Number Z-1588-2013 REASON If the operator selects a patient name...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 7/3/2013 Class ll: PRODUCT CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system...Read More

Company: GE Healthcare ITDate of Enforcement Report: 7/3/2013 Class ll: 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 designed...Read More

Company: Tecan US, Inc.Date of Enforcement Report: 6/26/2013 ClassL ll: PRODUCT Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational...Read More

Company: GE Healthcare.Date of Enforcement Report: 6/26/2013 ClassL ll: PRODUCT GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5...Read More

Company: Hitachi Medical Systems America Inc Date of Enforcement Report: 6/26/2013 ClassL ll: PRODUCT Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the...Read More

Company:Respironics, Inc Date of Enforcement Report6/20/13 Date Recall Initiated: 6/2/2013 Class l: PRODUCT Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631)...Read More

Company: American Optisurgical.Date of Enforcement Report: 6/12/2013 ClassL Ill: PRODUCT Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. Recall Number Z-1441-2013 REASON Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different...Read More

Company:Symbios Medical Products.Date of Enforcement Report 6/12/2013 Class I: PRODUCT Part 510031 Disposable Single Infusion Pump, quantity Includes… TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO… found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 – BP, w/ Epidural...Read More

Company: American Optisurgical. Date of Enforcement Report: 6/12/2013 Class ll: PRODUCT American Optisurgical’s TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. Recall Number Z-1516-2013 REASON The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board....Read More

Company: Beckman Coulter Inc.Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration...Read More

Company: Intel-GE Care Innovations LLC .Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. Recall Number Z-1374-2013 and Z-1375-2013 REASON ers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. RECALLING FIRM/MANUFACTURER Intel-GE...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-1419-2013 REASON Under some circumstances, imported CT, MR and...Read More

Company: Canon Inc.Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. Recall Number Z-1404-2013 REASON Canon Inc. had received 17 claims from our foreign...Read More

Company: Alpine Biomed Aps.Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524,...Read More

Company: Linvatec Corp. dba ConMed Linvatec Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. Recall Number Z-1340-2013 REASON The VP1600 HD Still Capture Image System is recalled due to an anomaly...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips...Read More

Company: Medical Information Technology, Inc.Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH’s Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information. Recall Number Z-1365-2013 REASON Incorrect transmission of laboratory results. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood,...Read More

Company: Olympus America Inc. Date of Enforcement Report: 5/15/2013 Class ll: PRODUCT Olympus SurgMaster UES-40 electrosurgical unit (“UES-40”) Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed...Read More

Company: GE Healthcare LLCDate of Enforcement Report: 5/8/2013 Class ll: PRODUCT GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device. Recall Number Z-1208-2013 REASON GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from...Read More

Company:Siemens MedicalDate of Enforcement Report 5/8/2013 Class ll: PRODUCT Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of...Read More

Company: GE Healthcare.Date of Enforcement Report: 5/8/2013 Class ll: PRODUCT GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device. Recall Number Z-1207-2013 REASON GE Healthcare has recently become aware of a Reformat Image Flip Issue associated...Read More

Company:GE HealthcareDate of Enforcement Report 5/1/2013 Class ll: PRODUCT GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/1/2013 Class ll: PRODUCT AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications...Read More

Company: Stellate SystemsDate of Enforcement Report: 5/1/2013 Class ll: PRODUCT Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle...Read More

Company: Horiba Instruments, Inc dba Horiba Medical .Date of Enforcement Report: 4/24/2013 Class ll: PRODUCT HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes. Recall Number Z-1141-2013 REASON HORIBA Medical is informing all ABX PENTRA 400 Analyzer with...Read More

Company:Carefusion Corp..Date of Enforcement Report 4/24/2013 Class I: PRODUCT Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Recall Number Z-1098-2013 REASON The recall was initiated because Carefusion has received reports of a communication error on...Read More