Company:General Electric Medical Systems Information TechnologyDate of Enforcement Report 5/13/2009 Class:ll PRODUCT GE Healthcare CIC Pro” Software Versions 5.0.3, 5.0.6 , 5.0.7, 5.0.8 and 4.1. The CIC Pro” Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult,...Read More

Company:Cerner Corp.Date of Enforcement Report 5.6/2009 Class:ll PRODUCT Cerner Bridge Medical Transfusion Administration and Specimen Collections, Recall # Z-1236-2009 REASON Specimen labels printing incorrect patient demographics RECALLING FIRM/MANUFACTURER Cerner Corp, Kansas City, MO, by letter dated January 15, 2009. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 4 units DISTRIBUTION OH, NC, MO...Read More

Company:Cardinal Health Date of Enforcement Report 5/6/2009 Class:ll PRODUCT Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1. Recall # Z-1237-2009 REASON The Alaris PCA module can potentially infuse above or below the intended infusion dose. RECALLING FIRM/MANUFACTURER Cardinal Health 303...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 5/6/2009 Class:ll PRODUCT syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system. Recall # Z-1266-2009 REASON An issue concerning...Read More

Company:GE Medical SystemsDate of Enforcement Report 4/22/2009 Class:ll PRODUCT a) GE Healthcare Infinia, Model Numbers: a) ASM000886, b) ASM001333, c) ASM001391, d) ASM001465, e) ASM001473, f) ASM001620, g) ASM500016, h) H3000WM, i) H3000WT, j) H3000WY and k) SYS000041. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in...Read More

Company:Smiths Medical MD, IncDate of Enforcement Report 4/22/2009 Class:ll PRODUCT a) Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients but, can also be used in a healthcare facility, Recall # Z-0988-2009; b) Deltec...Read More

Company:Viasys Healthcare .Date of Enforcement Report 4/15/2009 Class:ll PRODUCT a) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins, Recall # Z-0998-2009; b) Viasys Healthcare ,...Read More

Company:Abbott Laboratories.Date of Enforcement Report 4/15/2009 Class:ll PRODUCT CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode...Read More

Company: Medtronic, Inc.Date of Enforcement Report 4/15/2009 Class:lll PRODUCT Medtronic RV Lead Integrity Alert, Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators, Recall # Z-1172-2009 REASON Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R)...Read More

Company:Roche Diagnostics Corp.Date of Enforcement Report 4/15/2009 Class:ll PRODUCT a) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module; GMMI No. 04998618001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall #...Read More

Company:Cerner Corp.Date of Enforcement Report 4/8/2009 Class:ll PRODUCT Cerner HNA Classic PathNet Blood Bank Donor, versions 306 and 015, 510(k) #BK950055, Recall # B-0677-09 REASON Software with a glitch or defect was distributed. RECALLING FIRM/MANUFACTURER Cerner Corp., Kansas City, MO, by website on March 11, 2009, e-mailed on March 12, 2009 and registered mail on...Read More

Company:GE Healthcare.Date of Enforcement Report 4/8/2009 Class:ll PRODUCT GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be...Read More

At public conferences representatives of FDA have indicated that the draft Medical Device Data System Classification rule was returned from FDA legal review for clarification of how public comments were addressed. This will delay release of the final rule perhaps 3-6 months, but this is hard to estimate.Read More

Company:Leica MicrosystemsDate of Enforcement Report 4/1/2009 Class:ll PRODUCT QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen...Read More

Company:Bio-Rad Laboratories, Inc.Date of Enforcement Report 4/1/2009 Class:ll PRODUCT Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600. Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c, Recall...Read More

This SoftwareCPR.com newsletter lists items added to the website from Jan 1, 2009 to March 26, 2009 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and...Read More

Company:Bd Diagnostic Systems TripathDate of Enforcement Report 3/25/2009 Class:ll PRODUCT BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in...Read More

This link contains an August 2007 draft Korean KFDA guideline entitled “Medical Software Evaluation Guidelines.” This guidance focuses on examining information about the software and what it does, rather than how it may fail or risk management for those failures. There is significant emphasis and specificity in revision numbering and change control. Korea KFDA Software GuidelineRead More

Company: Baxter Healthcare Corp Date of Enforcement Report 3/11/2009 Class:l PRODUCT Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps Model numbers: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163 These products were manufactured and distributed from February, 1997 through December, 2008. REASON The company identified software and battery usage failures...Read More

/docs/JMurray-SoftwareDeviceClassification-AAMIStandardsConference031809.pdfRead More

Company: Zimmer, Inc Date of Enforcement Report 3/11/2009 Class:ll PRODUCT Orthosoft Navitrack, OS Unicondylar Knee 1.0 – Universal; software application for orthopedic surgical stereotaxic instrument. Recall # Z-0985-2009 REASON Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use...Read More

Company: Smiths Medical MD, Inc Date of Enforcement Report 3/11/2009 Class:ll PRODUCT a) Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. The Medfusion 3500 pump is a small, lightweight and portable syringe infusion pup. The pump offers a variety of delivery modes to program to meet specific patient care needs. The Medfusion...Read More

Company: Welch Allyn Protocol, Inc Date of Enforcement Report 3/11/2009 Class:l PRODUCT Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively “AED 10”). Recall # Z-1006-2009 REASON Reliability issues – potential to shock a non shockable rhythm or not shocking a shockable rhythm; CODE Software version 2.02 or lower. The ECG analysis/noise issue...Read More

Company:Philips Ultrasound, Inc Date of Enforcement Report 3/4/2009 Class:ll PRODUCT a) Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body. Recall # Z-0522-2009; b) Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System. Product also marketed...Read More

Company:GE Healthcare Integrated IT Solutions Date of Enforcement Report 3/4/2009 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS (Picture Archiving and Communication System) 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....Read More

Company:Haemonetics Software Solution Div Date of Enforcement Report 2/25/2009 Class:ll PRODUCT Prelude module of Symphony System software. Recall # B-0520-09 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Haemonetics Software Solution Div., Rosemont, IL, by telephone on November 14, 2008 and follow-up letters dated November 18, 2008. Firm initiated recall is ongoing....Read More

Company:Varian Medical SystemsDate of Enforcement Report 2/25/2009 Class:ll PRODUCT Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0. Recall # Z-0861-2009 REASON Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and...Read More

Company:Mako Surgical Date of Enforcement Report 2/25/2009 Class:ll PRODUCT a) Femoral Array, Model number: 0150ARR00001 and b) Tibial Array, Model number: 0150ARR00002. The devices are accessories used with MAKO’s Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to...Read More

Company:GE Healthcare Integrated IT Solutions Date of Enforcement Report 2/18/2009 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). 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 is also intended for...Read More

Company:Philips Healthcare Informatics, Inc Date of Enforcement Report 2/18/2009 Class:ll PRODUCT iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3. Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and...Read More

Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 2/18/2009 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS (Picture Archiving and Communication System) 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...Read More

Company:Medtronic Navigation, Inc Date of Enforcement Report 2/11/2009 Class:ll PRODUCT Medtronic O-Arm Intraoperative Imaging System, Catalog number: Bl-700-0027, Recall # Z-0624-2009 REASON Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker. RECALLING FIRM/MANUFACTURER Recalling...Read More

These two draft standards for networked medical devices and for medical device software risk management have been renumbered IEC 80001-1 and IEC 80002-1 respectively. IEC 80002-1 was released for a 3 month ballot period Jan 16, 2009.Read More

The Carnegie Mellon Software Engineering Institute performs a number of research projects each year. Their december report on these projects is at the link provided. One of the projects was on safety cases for medical devices. Sherman Eagles of SoftwareCPR and Paul Jones of FDA participated in this project.TECHNICAL REPORT CMU/SEI-2008-TR-025 ESC-TR-2008-025 SEI assurance case...Read More

Company:GE Healthcare Integrated IT Solutions. Date of Enforcement Report 2/4/2009 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout...Read More

Company: iCAD, Inc. Date of Enforcement Report 2/4/2009 Class:ll PRODUCT a) CAD SCIENCES LLC 3 TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. Recall # Z-0653-2009; b) CAD SCIENCES LLC 3 TP PrecisionPointTM Software, for biopsy guidance. Recall # Z-0654-2009; REASON Software modules not approved for this indication. RECALLING...Read More

CompanyGE Medical SystemsDate of Enforcement Report 1/28/2009 Class:ll PRODUCT a) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System. The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic...Read More

Company: TomoTherapy, IncDate of Enforcement Report 1/28/2009 Class:ll PRODUCT TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy...Read More

Company:Baxter Healthcare CorpDate of Enforcement Report 1/23/2009 Class:l PRODUCT Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps REASON The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IllinoisRead More

Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 1/21/2009 Class:ll PRODUCT Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC. Recall # Recall # Z-0870-2009 REASON Software error: There are two potential safety...Read More

Company: Accuray, Inc. Date of Enforcement Report 1/28/2009 Class:ll PRODUCT Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when...Read More

Company: Dade Behring, Inc Date of Enforcement Report 1/21/2009 Class:ll PRODUCT Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use. Recall # Z-0581-2009 REASON Error...Read More

Company: Beckman Coulter Inc Date of Enforcement Report 1/21/2009 Class:ll PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one...Read More

Company: ThomoTherapy Inc. Date of Enforcement Report 1/14/2009 Class:ll PRODUCT ThomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy, Recall # Z-0339-2009 REASON Treatment plans involving very small structures (volumeRead More

Company: Hitachi Medical Systems America IncDate of Enforcement Report 1/14/2009 Class:ll PRODUCT Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 1/14/2009 Class:ll PRODUCT CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System, Recall # Z-0647-2009 REASON Indicated orientation does not match actual orientation of the patient.. RECALLING FIRM/MANUFACTURER Recalling...Read More

Company: Beckman Coulter Inc Date of Enforcement Report 1/14/2009 Class:ll PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2, Recall # Z-0455-2009 REASON Software error: The CXP User documentation does not adequately characterize the use of the Live Gate feature. RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter Inc., Brea, CA,...Read More

Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 1/7/2009 Class:ll PRODUCT GE Centricity Ultra Laboratory System Software for recording, reporting and distribution of lab results, Recall # Z-0472-2009 REASON Software computer error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range. RECALLING...Read More

Company: Hologic, IncDate of Enforcement Report 12/31/2008 Class:ll PRODUCT Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software, Recall # Z-0449-2009 REASON Software error may lead to a high estimate of major fracture probability. RECALLING FIRM/MANUFACTURER Hologic, Inc., Bedford , MA , by telephone on September 23-24, 2008 and by...Read More

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