This SoftwareCPR.com newsletter lists items added to the website from March 26, 2009 to November 9, 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: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

The EU standardization organizations, CEN and CENELEC, have formed a joint working group on standards for software and medical devices (SAMD). The first meeting will be December 8th. Notice is at the link provided. With the harmonization of IEC 62304 (including for IVD devices), potential modifications to the scope of 60601, and the recent Medical...Read More

The European Commission Borderline and Classification committee has put out a call for software experts to join a working group on qualification and classification of software. The first meeting will be December 2nd, and will be chaired by Lennart Philipson from the Swedish Medical Products Agency. The Medical Information System report from Sweden has been...Read More

The Carnegie Mellon Software Engineering Institute continued work on safety assurance cases for medical devices by publishing a paper entitled “Towards an Assurance Case Practice for Medical Devices” doing an example case for an infusion pump. The full article is at the link provided. Although this is intended uses infusion pumps as an example it...Read More

For those using or interested in the SEI’s Capability Maturity Model, the link provided contains a white paper comparing IEC 62304 and the CMMi. This white paper was prepared by David Walker, a consultant that is a licensed SEI partner. It is published here with his permission. 62304-CMMi-comparison-DWalker092909Read More

/Docs/NASASoftwareSafetyGuidebook871913-2004.pdfRead More

This topic includes links to software safety guidance from other safety related industries that have useful information that could be applied to medical device software. All of these and sometimes others are in the document library section of the website.Read More

/docs/FDATraining-Module7IEC62304-BECSconferencePresentation-JMurray110409.pdfRead More

/docs/FDA-MDDSpresentation4BECSConference-JMurray110409.pdfRead More

/docs/FDACybersecurityReminder110409.pdfRead More

Sandy Hedberg of SoftwareCPR reported that at the BECS conference Nov. 4-5, 2009 Brian Fitzgerald of FDA gave a presentation in which use of virtual machines was mentioned. Sandy’s synopsis is: Brian Fitzgerald of FDA discussed use of the emerging technology, of virtual machines. A virtual machine is a hardware emulation layer of an operating...Read More

Health Canada now indicates that patient management software fits the definition of a medical device. “Any patient management software used only for archiving or viewing information or images, and not involved in the primary acquisition, manipulation and transfer of data, is considered a Class I medical device based on Rule 12 of the Medical Devices Regulations.”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

/docs/FDAdraftImagingCADesubmissionguidance102109.pdfRead 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 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: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

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm187084.htm#7Read 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: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: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: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: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: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: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

CDRH moved to a new location. The address of the document mail center for submissions and related communications is now: U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002Read 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: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

“IEC TR 80002-1 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software” has been released. This standard was based on AAMI TIR32 but focuses on the 14971 perspective. AAMI has adopted TR 80002-1 as well and may obsolete TIR32 although there are some areas where TIR32 is...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: 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: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: 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: 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: 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: 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

Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 7/22/2009 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation software (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: Gendex Dental SystemsDate of Enforcement Report 7/22/2009 Class:ll PRODUCT Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images. Recall # Z-1548-2009 REASON There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software...Read More

Company: Philips Medical SystemsDate of Enforcement Report 7/22/2009 Class:ll PRODUCT TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different...Read More

Company: Philips Medical SystemsDate of Enforcement Report 7/8/2009 Class:ll PRODUCT Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. The ‘Brilliance iCT’ is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray...Read More

Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 7/8/2009 Class:ll PRODUCT GE Centricity PACS (Picture Archiving and Communication System) software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. Recall # Z-1549-2009 REASON There is a potential safety issue associated with the use of...Read More

Recipient: Brymill CorporationProduct: liquid nitrogen cryosurgical devices Date: 2/18/09 The inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act (21 U.S.C. 351 (h)), in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage or installation are not in conformity with...Read More

Company: Philips Healthcare, IncDate of Enforcement Report 6.17/2009 Class:ll PRODUCT CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for...Read More

Company:Terumo Cardiovascular Systems CorpDate of Enforcement Report 6/10/2009 Class:ll PRODUCT Terumo Advanced Perfusion System 1 Central Control Monitor; Catalog number 802100. The Central Control Monitor (CCM) provides a centralized display of system information and on-screen control of all system devices. The CCM combines an embedded computer, a touchscreen, and a graphical user interface. Recall #...Read More

Company: Abbott LaboratoriesDate of Enforcement Report 6/3/2009 Class:ll PRODUCT Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01. Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube...Read More