Company Spacelabs Healthcare, Llc.Date of Enforcement Report:4/9/2014 Class lII: PRODUCT TDWorkstation version 11.01.A or higher. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS). Recall Number Z-1310-2014 REASON If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send...Read More

Company RAYSEARCH LABORATORIES AB.Date of Enforcement Report:4/9/2014 Class lI: PRODUCT RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software.Recall Number Z-1308-2014 REASON RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy. RECALLING FIRM/MANUFACTURER RAYSEARCH LABORATORIES AB, Stockholm, Sweden on.2/6/2014. Voluntary: Firm Initiated recall is ongoing....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/9/2014 Class lI: PRODUCT Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. Recall Number Z-1312-2014 REASON Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from...Read More

Company Velocity Medical Solutions, LLC.Date of Enforcement Report:4/2/2014 Class lI: PRODUCT DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume...Read More

Company Bio-Rad Laboratories, Inc.Date of Enforcement Report:4/2/2014 Class lI: PRODUCT D-10″ Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution,...Read More

Company Spacelabs Healthcare, Llc.Date of Enforcement Report:4/2/2014 Class lI: PRODUCT Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers. Recall Number Z-1273-201 REASON Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report:3/26/2014 Class lI: PRODUCT syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 Recall Number Z-1216-2014 REASON Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient...Read More

Company Medical Information Technology, Inc..Date of Enforcement Report:3/26/2014 Class lI: PRODUCT MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS). Recall Number Z-1234-2014 REASON Potential for erroneous result reporting.. RECALLING FIRM/MANUFACTURER Medical Information...Read More

Company: GE Healthcare LLC Date of Enforcement Report:3/26/2014 Class lI: PRODUCT GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/262014 Class lI: PRODUCT Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of...Read More

Company: GE Healthcare LLC Date of Enforcement Report:3/19/2014 Class lI: PRODUCT The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/19/2014 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 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...Read More

Company:Elekta, Inc.Date of Enforcement Report:3/19/2014 Class lI: PRODUCT XiO RPT 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

CompanyHoriba Instruments, Inc dba Horiba Medical.Date of Enforcement Report:3/19/2014 Class lI: PRODUCT Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.Recall Number Z-1173-2014 REASON HORIBA...Read More

Company:Elekta, Inc.Date of Enforcement Report:3/19/2014 Class lI: PRODUCT RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging. RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal...Read More

Company:McKesson Technologies,.Date of Enforcement Report:3/15/2014 Class I: PRODUCT McKesson Anesthesia Care Use: The device is a computer-based system which collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment. The system provides clinical decision support by communicating potential adverse drug event...Read More

Company:Elekta, Inc.Date of Enforcement Report:3/12/2014 Class lI: PRODUCT Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators. Recall Number Z-1083-2014 REASON During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. RECALLING FIRM/MANUFACTURER Elekta Inc.,...Read More

Company:Elekta, Inc.Date of Enforcement Report:3/12/2014 Class lI: PRODUCT TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. Recall Number Z-0972-2014 REASON Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta...Read More

Company: GE Healthcare LLC Date of Enforcement Report:3/12/2014 Class lI: PRODUCT GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW...Read More

Company:Elekta, Inc.Date of Enforcement Report:3/12/2014 Class lI: PRODUCT 1. Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators. Recall Number Z-1084-2014 2. Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital...Read More

Company:Elekta, Inc.Date of Enforcement Report:3/12/2014 Class lI: PRODUCT RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical...Read More

Company:Toshiba American Medical Systems IncDate of Enforcement Report:3/12/2014 Class lI: PRODUCT TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display...Read More

Company: GE Healthcare LLC Date of Enforcement Report:3/12/2014 Class lI: PRODUCT GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report:3/52014 Class lI: PRODUCT M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 3/5/2014 Class lI: PRODUCT GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 2/26/2014 Class lI: PRODUCT GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means...Read More

Company:Elekta, Inc.Date of Enforcement Report:2/26/2014 Class lI: PRODUCT Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs – (1) You do an online VolumeView acquisition and registration. (2) You accept the...Read More

Company:Ortho-Clinical Diagnostics Date of Enforcement Report:2/19/2014 Class lI: PRODUCT VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the...Read More

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