Company:Hospira Inc.Date of Enforcement Report: 7/16/2014 Class lI: PRODUCT GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. Recall Number Z-2031-2014 REASON Through customer complaints, Hospira has...Read More

Company: Nihon Kohden America IncDate of Enforcement Report:6/25/2014 Class lI: PRODUCT CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients. Recall Number Z-1979-2014 REASON Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting...Read More

Company: Focus Diagnostics IncDate of Enforcement Report:6/25/2014 Class lI: PRODUCT Simplexa” Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa” Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and...Read More

Company:Baxter Healthcare Corp.Date of Enforcement Report: 7/9/2014 Class lI: PRODUCT EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/9/2014 Class lI: PRODUCT ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. Recall Number Z-1962-2014 REASON There is a potential measurement error with the Auto-Stats (auto statistics) measurement...Read More

Company:Elekta, Inc.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Z-1800-2014. REASON When using CMA, if the user hovers the mouse pointer exactly above...Read More

Company:Elekta, Inc.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment. Recall Number Z-1807-2014 REASON A bug in the software prevents the iGUIDE software from logging off. RECALLING FIRM/MANUFACTURER...Read More

Company:Elekta, Inc.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT Synergy XVI Intended for radiation therapy treatment. Recall Number Z-1724-2014 REASON XVI can incorrectly calculate the target position of the treatment table.. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta GA. on 4/23/2014. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 380 US DISTRIBUTION Nationwide and Internationally...Read More

Company: Roche Diagnostics Operations, Inc.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator’s Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. Recall Number...Read More

Company:RAYSEARCH LABORATORIES AB.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-1806-2014 REASON This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/18/2014 Class lI: PRODUCT IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 Recall Number Z-1746-2014 REASON IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT enGen (TM) Laboratory Automation Systems (enGen) with TCAutomation (TM) — For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. — Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes...Read More

Company: Mckesson Medical Immaging.Date of Enforcement Report:6/18/2014 Class lI: PRODUCT Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management 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-1728-2014 REASON...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/18/2014 Class lI: PRODUCT Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor. Recall Number Z-1783-2014 REASON If a customer creates customized trend scales in the trend review tile and the iX or...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT enGen (TM) Laboratory Automation System Configured with TCAutomation” Software v3.5 — For in vitro quantitative measurement of a variety of analytes of clinical interest — The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. Recall Number Z-1734-2014 REASON Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use. Recall Number Z-1736-2014 REASON Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use. Recall Number Z-1735-2014 REASON Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1...Read More

Company: Spacelabs Healthcare Inc Date of Enforcement Report:6/11/2014 Class lI: PRODUCT Spacelabs Medical Ultraview SL” Command Module, Model 91496. Detector and alarm, arrhythmia. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type...Read More

Company: BRainlab AG.Date of Enforcement Report:6/11/2014 Class lI: PRODUCT Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or...Read More

Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report:6/11/2014 Class lI: PRODUCT IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing. Recall Number Z-1678-2014 REASON During SPECT reconstructions using Attenuation Correction and Scatter...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/11/2014 Class lI: PRODUCT enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 — For in vitro quantitative measurement of a variety of analytes of clinical interest — Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition...Read More

Company: Toshiba American Medical Systems IncDate of Enforcement Report:6/11/2014 Class lI: PRODUCT Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting. Recall Number Z-1714-2014 REASON Toshiba America Medical Systems, Inc. initiated a recall of Toshiba Infinix X-Ray (INFX-8000V/UU), because it has been...Read More

Company: BRainlab AG.Date of Enforcement Report:6/11/2014 Class lI: PRODUCT ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. Recall Number Z-1707-2014 REASON When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/4/2014 Class lI: PRODUCT ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Recall Number Z-1667-2014 REASON Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) – may incorrectly display the color flow data in the wrong position and when...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/42014 Class lI: PRODUCT ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Recall Number Z-1668-2014 REASON Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could...Read More

Company: GE Healthcare Date of Enforcement Report:6/4/2014 Class lI: PRODUCT The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The...Read More

Company: Physio-Control, Inc.Date of Enforcement Report:6/42014 Class lI: PRODUCT LIFEPAK 1000 defibrillator. The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. Recall Number Z-1660-2014 REASON Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to...Read More

Company: NAGFA Corp.Date of Enforcement Report:6/4/2014 Class lI: PRODUCT IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography. Recall Number Z-1662-2014 REASON Failure to effectively install and test a hotfix to correct the...Read More

Company: Philips Healthcare Informatics, Inc.Date of Enforcement Report 5/28/2014 Class lI: PRODUCT Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/28/2014 Class lI: PRODUCT 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer. Recall Number Z-1645-2014 REASON Table may lose calibration during patient treatment, which may cause the possibility of mistreatment. RECALLING FIRM/MANUFACTURER Siemens Medical...Read More

Company: GE Healthcare Date of Enforcement Report:5/28/2014 Class lI: PRODUCT GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. The device is indicated for use by qualified medical personnel only. Recall Number Z-1640-2014 REASON When...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/28/2014 Class lI: PRODUCT syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also...Read More

Company: Baxter Corporation EnglewoodDate of Enforcement Report:4/2/2014 Class I: PRODUCT Baxter Corporation Englewood, ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0 – Software Errors May Cause Toxic or Overdose Symptoms. ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition),...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: 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: 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: 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: 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: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