Company:Haemonetics Software SolutionsDate of Enforcement Report 3/24//2010 Class:ll PRODUCT Surround System software. Recall # B-0737-10 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Haemonetics Software Solutions, Rosemont, IL, by e-mail on July 25, 2008. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 35 units DISTRIBUTION DC, FL, HI, IL, IN,...Read More

Company:Beckman Coulter Inc.Date of Enforcement Report 3/17/2010 Class:l PRODUCT 1) Coulter LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean...Read More

Company:Baxter Healthcare Corporation.Date of Enforcement Report 3/4/2010 Class:l PRODUCT Baxter Healthcare Corporation, HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. These systems have been distributed since 1990 REASON Baxter is conducting a recall of the HomeChoice and HomeChoice PRO because of reports of serious injuries and at least one death associated with increased Intraperitoneal Volume...Read More

Company:Remel, Inc.Date of Enforcement Report 3/3//2010 Class:ll PRODUCT ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like, and related organisms isolated from human clinical specimens. A complete listing of...Read More

Company:Cybernet Systems CorpDate of Enforcement Report 3/3/2010 Class:ll PRODUCT 1) Cybernet Medical MedStar Telemedicine System; Model 533-210. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data...Read More

Company:Stryker ImagingDate of Enforcement Report 2/17/2010 Class:ll PRODUCT Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan. Recall # Z-0134-2010 REASON Firm has determined Guardian Services does not contain 100% data backup for...Read More

Company:Sendx Medical IncDate of Enforcement Report 2/17/2010 Class:ll PRODUCT ABL 80 CO-OX System, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX System is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The...Read More

Company:GE HealthcareDate of Enforcement Report 2/3/2010 Class:ll PRODUCT 1) iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD. Recall # Z-0600-2010; 2) Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2, 13.0, & 13.1....Read More

Company:GE Medical SystemsDate of Enforcement Report 2/3/2010 Class:ll PRODUCT GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages...Read More

Company:GE HealthcareDate of Enforcement Report 2/3/2010 Class:ll PRODUCT 1) GE OEC 9900 Elite ESP, to produce mobile fluoroscopic images of human anatomy. Recall # Z-0004-2010; 2) GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy. Recall # Z-0005-2010 REASON A software defect – may result in a false indication and...Read More

Company:Edwards Lifesciences Inc.br>Date of Enforcement Report 1/11/2010 Class:l PRODUCT Edwards Lifesciences “Aquarius” System; Model Numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The Aquarius monitors the fluid going into and coming out of the patient. Recall # Z-0653-2010 This product was manufactured from July 12, 2007 through March 18, 2009 and distributed...Read More

Company:Hocoma AG,br>Date of Enforcement Report 1/27/2010 Class:ll PRODUCT Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x. Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients. Recall # Z-0590-2010 REASON Changes to the stored “sensitivity” values may occur and leads to higher limits in...Read More

Company:Philips Healthcare IncDate of Enforcement Report 1/27/2010 Class:ll PRODUCT 1) SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4″display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4″ display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4″...Read More

Company:General Electric Medical Systems Information TechnologyDate of Enforcement Report 1/20/2010 Class:ll PRODUCT GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software). Recall # Z-0631-2010 REASON Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator’s Manual may impact patient safety. When ApexPro...Read More

Company:Smiths Medical.ASD Inc.Date of Enforcement Report 1/20/2010 Class:ll PRODUCT 1) Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Recall # Z-0650-2010; 2) Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Recall # Z-0651-2010 REASON Smiths Medical has become aware of an increased trend in...Read More

Company:GE Medical Systems, LLCDate of Enforcement Report 1/13/2010 Class:ll PRODUCT GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems. Recall # Z-0541-2010 REASON GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8...Read More

Company:Draeger Medical, Inc.Date of Enforcement Report 1/6/2010 Class:ll PRODUCT Delta/Delta XL Monitors with Omega S Package. Catalog numbers MS18597 and MS18596. Recall # Z-0582-2010 REASON Monitor is rebooting/resetting. RECALLING FIRM/MANUFACTURER Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter dated November 2009. Manufacturer: Draeger Medical Systems Inc., Danvers, MA. Firm initiated recall is ongoing. VOLUME...Read More

Company:BioTek Instruments, Inc.Date of Enforcement Report 12/30/2009 Class:ll PRODUCT BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application. Recall # Z-2223-2009 REASON Software design allowed false negatives to be read when wells are dark. RECALLING FIRM/MANUFACTURER...Read More

Company:GE Medical Systems, LLC.Date of Enforcement Report 12/30/2009 Class:ll PRODUCT Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434. Recall # Z-0002-2009 REASON GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that...Read More

Company:GE Healthcare Integrated IT Solutions.Date of Enforcement Report 12/16/2009 Class:ll PRODUCT GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. Recall # Z-0456-2010 REASON There are potential safety issues, including misdiagnosis or delay in...Read More

Company:Picis, Inc.Date of Enforcement Report 12/9/2009 Class:ll PRODUCT PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. Recall # Z-0365-2010 REASON Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between...Read More

Company:Cyberonics, Inc.Date of Enforcement Report 12/9/2009 Class:ll PRODUCT Cyberonics VNS Therapy Demipulse Generator Model 250 Programming System, version 4.6, 6.1, 7.0, and 7.1 labeling, for vagus nerve stimulation. Recall # Z-0264-2010 REASON Failure to deliver therapy. Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test...Read More

Company:Baxter Healthcare Renal DivisionDate of Enforcement Report 12/3/2009 Class:ll PRODUCT System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by...Read More

Company:Varian Medical Systems Oncology Systems.Date of Enforcement Report 11/25/2009 Class:ll PRODUCT VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Recall # Z-0133-2010 REASON Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will...Read More

Company:GE Medical Systems Information Tecnology.Date of Enforcement Report 11/18/2009 Class:ll PRODUCT 1) Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients. Recall # Z-1994-2009; 2) Datex-Ohmeda...Read More

Company:IMTEC IMAGING L.L.C.Date of Enforcement Report 11/12/2009 Class:ll PRODUCT ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in...Read More

Company:GE Healthcare Integrated IT SolutionDate of Enforcement Report 10/28/2009 Class:ll PRODUCT Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software. The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images. Recall # Z-2316-2009 REASON Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study...Read More

Company:Roche Molecular Systems, IncDate of Enforcement Report 10/21/2009 Class:ll PRODUCT AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS...Read More

Company:Neuro Kinetics.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing. Recall # Z-2253-2009 REASON Marketed without a 510k or PMA submission to include the normative data display. RECALLING FIRM/MANUFACTURER Neuro Kinetics, Pittsburgh, PA, by letter on August 10, 2009....Read More

Company:Brainlab AG.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 – Radiosurgery 3.0 Catalog number 20620 – Radiosurgery 3.5 and Catalog number 20630 – Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and...Read More

Company:Varian Medical Systems Oncology Systems.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. Recall # Z-2231-2009 REASON Software Issue/Mistreatment Potential — Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.. RECALLING FIRM/MANUFACTURER Varian...Read More

Company:Varian Medical Systems Oncology SystemsDate of Enforcement Report 10/21/2009 Class:ll PRODUCT Varis, Aria Radiation Oncology – Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the...Read More

Company:Cardinal Health Manufacturing, LLC, .Date of Enforcement Report 10/21/2009 Class:ll PRODUCT Pyxis Anesthesia System 3500, The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia...Read More

Company:Varian Medical Systems Oncology Systems.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT Clinac with Version 7.x Software. Model Numbers: H14, H27 and H29. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy. Recall # Z-1729-2009 REASON Unexpected Movement: if the stereotactic...Read More

Company:Micro Typing Systems, Inc.Date of Enforcement Report 10/14/2009 Class:ll PRODUCT Ortho ProVue, Product Code MTS213784. Recall # B-1268-09 REASON Software, with an anomaly (Versions 2.16 and below) affecting transmission of results from the Ortho ProVue using a bi-directional Laboratory Information System (LIS) interface, was distributed. RECALLING FIRM/MANUFACTURER Recalling Firm: Micro Typing Systems, Inc., Pompano Beach,...Read More

Company:Toshiba Medical Systems Co.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Recall # Z-0005-2009 REASON Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in...Read More

Company:AGFA Corp.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa’s Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis. Recall # Z-1889-2009 REASON After opening and closing a study on a Central Monitoring System while...Read More

Company:Carl Zeiss Meditec Inc.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of...Read More

Company:Hologic Inc.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT 1) Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body...Read More

Company:Perkin Elmer.Date of Enforcement Report 9/30/2009 Class:ll PRODUCT a) Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results. Recall # Z-1905-2009; b) Specimen Gate Lab – MSMS Data Suite,...Read More

Company:Hitachi Medical Systems America Inc., .Date of Enforcement Report 9/30/2009 Class:ll PRODUCT 1) EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. Recall # Z-2054-2009; 2) EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and...Read More

Company:American Optisurgical Inc.Date of Enforcement Report 9/16/2009 Class:ll PRODUCT American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery. Recall # Z-1808-2009 REASON Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead...Read More

Company:Hospira Inc.Date of Enforcement Report 9/2/2009 Class:ll PRODUCT 1) Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1815-2009; 2) Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1816-2009 REASON Potential delay/under infusion of critical therapy–...Read More

Company:GE Medical Systems, LLCDate of Enforcement Report 8/26/2009 Class:ll PRODUCT GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images, Recall # Z-1720-2009 REASON...Read More

Company:Veridex, LLCDate of Enforcement Report 8/26/2009 Class:ll PRODUCT CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater, Recall # Z-1734-2009 REASON Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System. RECALLING FIRM/MANUFACTURER Veridex, LLC, Raritan, NJ, by letter dated March 12,...Read More

Company: Cardinal HealthDate of Enforcement Report 8/26/2009 Class:l PRODUCT 1) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above, Recall # Z-1790-2009; 2) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the...Read More

Company: Philips HealthcareDate of Enforcement Report 8/5/2009 Class:ll PRODUCT Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management, Recall # Z-1654-2009 REASON Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders’ original schedule time, ICIP can create a second instance of the same...Read More

Company: Hitachi Medical Corporation.Date of Enforcement Report 8/5/2009 Class:ll PRODUCT 1) Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less, Recall # Z-1651-2009; 2) Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version 2.11 or less, Recall # Z-1652-2009 REASON Incorrect scale on image: A software error can occur if two (2) different Field-of-View...Read More

Company: Welch Allyn Protocol, IncDate of Enforcement Report 8/5/2009 Class:ll PRODUCT Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively “AED 10”), Recall # Z-1656-2009 REASON Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing...Read More

Company: Philips Medical SystemsDate of Enforcement Report 7/29/2009 Class:ll PRODUCT 1) TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on the GEMINI TF 16 and GEMINI TF 64 Slice PET/CT Systems, Catalog Numbers: 882470 – GEMINI TF 16 Slice; 882471 – GEMINI TF 64 Slice; and 882473 – GEMINI TF 16 Slice...Read More