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

Company: Maquet Cardiovascular, LLC.Date of Enforcement Report: 4/24/2013 Class ll: PRODUCT MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for...Read More

Company:Carefusion Corp..Date of Enforcement Report 4/24/2013 Class Il: 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-1112-2013 REASON The recall was initiated because Carefusion has identified potential risk associated with bolus programming...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 4/24/2013 Class ll: PRODUCT Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/24/2013 Class ll: PRODUCT Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration,...Read More

Company:GE HealthcareDate of Enforcement Report 4/24/2013 Class ll: PRODUCT GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server...Read More

Company:AGFA Corp. .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. Recall Number Z-1070-2013 REASON Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the...Read More

Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Recall Number B-1345-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc, Auburn, WA, on 12/5/2012. Voluntary: Firm Initiated recall...Read More

Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning. Recall Number Z-1068-2013 REASON It has been found that due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a...Read More

Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation. Recall Number Z-1096-2013 REASON GE...Read More

Company:AGFA Corp. .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT IMPAX CV 7.8 SU3 – OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. Recall Number Z-1069-2013 REASON Software design...Read More

Company:Zyno Medical LLC .Date of Enforcement Report 4/10/2013 Class ll: PRODUCT Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. Recall Number Z-1024-2013 REASON Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the...Read More

Company:Philips Medical Systems .Date of Enforcement Report 4/10/2013 Class ll: PRODUCT Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall Number Z-1029-2013 REASON Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/10/2013 Class lll: PRODUCT Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids. Recall Number Z-1046-2013 REASON Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System...Read More

Company:Animas Corporation Date of Enforcement Report 4/10/2013 Class l: PRODUCT Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. Recall Number Z-0993-2013 REASON Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component...Read More

Company:Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 4/10/2013 Class ll: PRODUCT ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/10/2013 Class ll: PRODUCT SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS...Read More

Company:Biomerieux Inc .Date of Enforcement Report 4/3/2013 Class ll: PRODUCT VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700...Read More

CompanyVital Images, Inc. .Date of Enforcement Report 4/3/2013 Class ll: PRODUCT Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/3/2013 Class ll: PRODUCT Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system. Recall Number Z-0997-2013 REASON The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under...Read More

Company:Toshiba American Medical Systems Inc .Date of Enforcement Report4/3/2013 Class ll: PRODUCT Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. Recall Number Z-0994-2013 REASON Lost and incorrect images. When using the “F-Rec” fluoroscopy image acquisition recording option in the “manual mode” an infrequent software error may...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Siemens Somatom CT’s equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system. Recall Number Z-0948-2013 REASON Sporadic hang-up malfunctions concerning 3D reconstructions during activated “Preview Image” functionality RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. Z-0935-2013 REASON An error on the SR Viewer Reporting Tool...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This...Read More

Company:Beckman Coulter Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. Recall Number Z-0913-2013 REASON Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken...Read More

Company:Steris Corporation Date of Enforcement Report 3/13/2013 Class ll: PRODUCT AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. Recall Number Z-0915-2013 REASON The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/13/2013 Class ll: PRODUCT GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with...Read More

Company:Philips Healthcare Inc Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Philips Digital Diagnost Stationary radiographic system. Recall Number Z-0900-2013 REASON When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY. Recall Number Z-0907-2013 REASON Siemens...Read More

Company:Intel-GE Care Innovations LLC. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents’ movements. Recall Number Z-0877-2013 REASON Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall Number...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/6/2013 Class ll: PRODUCT GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts. Recall Number Z-0703-2013 and Z-0704-2013 REASON It was discovered GE Healthcare...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Ingenuity TF PET/CT Diagnostic imaging system Recall Number Z-0897-2013 REASON Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients. RECALLING FIRM/MANUFACTURER Philips...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System. Recall Number Z-0881-2013 REASON Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244. Recall Number Z-0880-2013 REASON Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, GEMINI LXL – Model #882412; GEMINI TF 16 – Model #882470 and Model #882473; GEMINI TF 64 – Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that...Read More

Company:Philips Healthcare Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system Recall Number Z-0884-2013 REASON When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/6/2013 Class ll: PRODUCT GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System Recall Number Z-0761-2013 REASON GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code...Read More

Company:Elekta, Inc. Date of Enforcement Report 2/27/2013 Class ll: PRODUCT Monaco RTP System. Radiation treatment planning. Recall Number Z-0841-2013 REASON The beam is displayed at the “gantry” angle, but the dose is calculated at the “rotation_start” angle. RECALLING FIRM/MANUFACTURER Elekta, Inc., Atlanta, GA,I on 2/11/2013. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:Varian Medical Systems, Inc. Oncology Systems Date of Enforcement Report 2/27/2013 Class ll: PRODUCT Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Recall Number Z-0867-2013 REASON Varian has identified an anomaly with the Eclipse...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 2/20/2013 Class ll: PRODUCT GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. Recall Number Z-0813-2013 REASON GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on...Read More

Company:Terumo Cardiovascular Systems Corporation Date of Enforcement Report 2/20/2013 Class ll: PRODUCT Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels. Recall Number Z-0802-2013 REASON Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size...Read More

Company:Mindray DS USA, Inc. d.b.a. Mindray North America Date of Enforcement Report 2/20/2013 Class ll: PRODUCT Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and...Read More

Company:Blood Bank Computer Systems, Inc Date of Enforcement Report 2/13/2013 Class ll: PRODUCT Blood Bank Control System (BBCS) Primary Application 5.0 – software for device. Recall Number B-0726-13 REASON Blood Bank software, with a defect or glitch, was distributed.. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc Auburn, WA on 10/18/2011. Voluntary: Firm Initiated recall is...Read More

Company:Dept Of Veterans Affairs Office Of Information & Technology Date of Enforcement Report 2/13/2013 Class ll: PRODUCT VistA Blood Establishment Computer Software (VBECS) Recall Number B-0673-13 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Dept Of Veterans Affairs Office Of Information & Technology, Hines, IL on 11/2/2012. Voluntary: Firm Initiated recall is...Read More

Company:Roche Molecular Systems, Inc. Date of Enforcement Report 2/6/2013 Class ll: PRODUCT COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. Recall Number Z-0762-2013 REASON The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test...Read More

Company:Hamilton Medical Inc. Date of Enforcement Report 2/6/2013 Class l: PRODUCT HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Recall Number Z-0741-2013 REASON Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high...Read More