Company: SCC Soft Computer Date of Enforcement Report:5/21/2014 Class lI: PRODUCT SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory...Read More

Company: Codman & Shurtleff, Inc Date of Enforcement Report:5/21/2014 Class lI: PRODUCT MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 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. Recall Number Z-1571-2014 REASON A...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/21/2014 Class lI: PRODUCT Syngo Dynamics Product Usage: Syngo Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for...Read More

Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)Date of Enforcement Report:5/21/2014 Class lI: PRODUCT Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. Recall...Read More

Company: Mckesson Medical ImagingDate of Enforcement Report:5/21/2014 Class lI: PRODUCT McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall Number Z-1617-2014 REASON High priority alert...Read More

Company: CareFusion 303, Inc.Date of Enforcement Report:4/23/2014 Class I: PRODUCT Alaris Pump Module (Model 8100), Software Version 9.1.18 The Alaris Pump Model 8100 is a large volume infusion pump. It is intended for use in health care facilities that use infusion for the delivery of fluids, medicines, blood, and blood products using continuous or periodic...Read More

Company: Shimadzu Medical Systems Date of Enforcement Report:5/14/2014 Class lI: PRODUCT Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices. Recall Number Z-1569-2014 REASON Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a...Read More

Company: INO Therapeutics Date of Enforcement Report:5/14/2014 Class lI: PRODUCT INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting...Read More

Company: GE Healthcare Date of Enforcement Report:5/14/2014 Class lI: PRODUCT Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with...Read More

Company: Hospira Inc..Date of Enforcement Report:5/7/2014 Class I: PRODUCT GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX Recall Number Z-1512-2014 REASON There...Read More

Company: Brainlab AG Date of Enforcement Report 5/7/2014 Class lI: PRODUCT ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X...Read More

Company: GE Healthcare LLC Date of Enforcement Report:5/7/2014 Class lI: PRODUCT GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #’s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting...Read More

Company: Baxter Healthcare CorporationDate of Enforcement Report:2/7/2014 Class I: PRODUCT Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB Affected products were manufactured from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014. Use: Sigma Spectrum Infusion Pumps with Master Drug Library are...Read More

Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report 4/30/2014 Class lI: PRODUCT RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0. Recall Number Z-1481-2014 REASON RaySearch Laboratories has recalled “RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0” software due to dose miscalculations for bolus/external/fixation support structures...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 4/30/2014 Class lI: PRODUCT VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II...Read More

Company: Boston Scientific Corporation Date of Enforcement Report 4/30/2014 Class lI: PRODUCT iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology. Recall Number Z-1487-2014 REASON Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to...Read More

Company:Ion Beam Applications S.A Date of Enforcement Report 4/30/2014 Class lI: PRODUCT Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy Recall Number Z-1492-2014 REASON Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/30/2014 Class lI: PRODUCT Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/16/2014 Class lI: PRODUCT Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator. Recall Number Z-1438-2014 REASON Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay...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 ZOLL Medical Corporation.Date of Enforcement Report:4/9/2014 Class lI: PRODUCT Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator. Recall Number Z-1311-2014 REASON Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used RECALLING FIRM/MANUFACTURER ZOLL Medical Corporation, Chelmsford, MA on.3/52014. Voluntary: Firm Initiated...Read More

Company:Elekta, Inc.Date of Enforcement Report:4/92/2014 Class lI: PRODUCT Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. Recall Number Z-1322-2014 REASON The problem is that the “static tolerances” from...Read More

Company RAYSEARCH LABORATORIES AB.Date of Enforcement Report:4/9/2014 Class lI: PRODUCT RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-1307-2014 REASON Potential for dose errors due to software program errors.. RECALLING FIRM/MANUFACTURER RAYSEARCH LABORATORIES AB, Stockholm, Sweden on.2/6/2014....Read More

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 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: 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: 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

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: 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

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 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: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: 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: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