http://www.61508.org/61508.htmRead More

Health Canada published a notice entitled “Software Regulated as a Class I or Class II Medical device,” along with a Q&A memo to clarify what software is regulated and which regulations apply. Both documents are included at the link provided. The notice appears to indicate that any software which fits the definition of a medical...Read More

/docs/SCPRed/SoftwareCPR-Newsletter1210.pdfRead More

Company: Impac Medical Systems IncDate of Enforcement Report 12/1/2010 Class ll: PRODUCT Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. Recall # Z-0159-2011 REASON Mistreatment–...Read More

Company: Varian MedicalDate of Enforcement Report 12/1/2010 Class ll: PRODUCT Varian brand TrueBeam and TrueBeam STx, Model Number: TMX- H19. Recall # Z-0106-2011 REASON Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects “Apply Shift” and presses Motion Enable buttons. This can result in the...Read More

Company: GE Healthcare ITDate of Enforcement Report 12/1/2010 Class ll: PRODUCT GE Centricity Laboratory Instrument Interface software. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. Recall # Z-0123-2011 REASON Instrument...Read More

Company: Medtronic Inc.Date of Enforcement Report 12/1/2010 Class ll: PRODUCT 1) Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that...Read More

The pdf at the link provided is a reprint of an article in the November 2010 issue of the Jounal of Medical Device Regulation entitled “US Medical Device Software Regulation”. This article was authored by Sherman Eagles, and Alan Kusinitz, Partners at SoftwareCPR.  The article provides an overview of FDA regulations related software distributed in...Read More

Company: SCC Soft ComputerDate of Enforcement Report 11/24/2010 Class ll: PRODUCT SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. Recall # Z-0088-2011 REASON Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a...Read More

Company: Impac Medical Systems, Inc. Date of Enforcement Report 11/24/2010 Class ll: PRODUCT Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class 11b. Recall # Z- 0076-2011 REASON Software issue; matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different...Read More

Company: Verathon, Inc. Date of Enforcement Report 11/17/2010 Class ll: PRODUCT 1) BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into...Read More

Company:Baxter Healthcare, Corp Date of Enforcement Report 11/17/10//2010 Class l: PRODUCT ) Baxter Colleague Single Channel Volumetric Infusion Pumps. Product Codes: 2M8151, 2M8161, and 2M9161. Recall # Z-0001-2011; 2) Baxter Colleague Triple Channel Volumetric Infusion Pumps. Product Codes: 2M 8153 and 2M 8163. Recall # Z-0002-2011; REASON The FDA sent a letter to Baxter on...Read More

/docs/MammographyGuidanceAddendum111610-UCM185904.pdfRead More

This website provides access to the latest lists of references of harmonised standards and other European standards. “Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.”Read More

Company: International Technidyne Corp Date of Enforcement Report 11/10/2010 Class lll: PRODUCT Integrated Data Management System – Version 7.1, 7.2 and 7.3; Product code 464100. Recall # Z-2438-2010 REASON A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in incorrect Electronic Quality Control (EQC) Summary Reports: The Operator and...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report 11/10/2010 Class ll: PRODUCT UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other...Read More

/docs/FFD-MammographyGuidance110510-ucm107553.pdfRead More

Company: GE HealthcareDate of Enforcement Report 10/27//2010 Class ll: PRODUCT GE Healthcare, CARESCAPE” Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE ” Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and...Read More

Company: AGFA Corp. Date of Enforcement Report 10/27//2010 Class ll: PRODUCT IMPAX CV Results Manager/Results Manager Administration Tool. Model No. L9M2100. Recall # Z-2112-2010 REASON Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators. RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by letter on June...Read More

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm229642.htmRead More

The slides from a SoftwareCPR presentation on compliant use of Agile Methods for medical device software development is at the link provided. This was prepared and presented by Brian Pate and Mike Russell and similar slides are used in SoftwareCPR’s public courses. SCPRed_AgileForMedicalDevices-SoftwareCPRpresentation101010Read More

At the October AAMI Software Validation Course the FDA instructor indicated that the device center is not participating in this and that the Drug center’s intent is to gather information on how companies handle electronic records and signatures and not to ramp up enforcement of Part 11.Read More

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm228613.htmRead More

Company: Sorin Biomedica C.R.M Date of Enforcement Report 9/29//2010 Class ll: PRODUCT Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Recall # Z-2579-2010 REASON The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and...Read More

Recipient: Perma Pure LLC.Product: moisture exchange gas dryers Date: 9/21/10 The inspection revealed that your 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 their manufacture, packing, storage, or installation are not in conformity with the...Read More

Company: Philips Medical Systems North America Co. Date of Enforcement Report 9/22//2010 Class ll: PRODUCT DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. Recall # Z-2422-2010 REASON When...Read More

The link provided is to a NASA website on software development, V&V, quality and safety assurance. There are links to many software checklists that may relevant or a starting point for tailoring for medical device software. There is also a link to the 1997 NASA software safety standard from their website. NASA Software Assurance WebsiteRead More

Company: Medtronic Inc Date of Enforcement Report 8/25//2010 Class ll: PRODUCT Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The...Read More

http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm081667.pdfRead More

FDA Center for Biologics Evaluation and Research released SOPP 8116 “Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff” Version #4 Effective Date: August 10, 2010. This describes their approach to using electronic signatures for certain regulatory approvals (including correspondence and premarket submissions) and is based on applying each person’s network profile identification via...Read More

Company: GE Healthcare It. Date of Enforcement Report 8/11//2010 Class ll: PRODUCT 1) GE Centricity PACS-IW software. Device that receives stores and communicates medical images and data from various imaging sources. Recall # Z-1402-201; 2)GE Centricity Web Diagnostic (WebDX) software; Device that receives stores and communicates medical images and data from various imaging sources. Recall...Read More

Company: Smiths Medical ASD, Inc. Date of Enforcement Report 8/11//2010 Class ll: PRODUCT Medfusion Syringe Infusion Pumps, Models 3010 and 3010a with Software Versions 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Recall # Z-2121-2010 REASON Smiths...Read More

Company: Haag-Streit USA Inc. Date of Enforcement Report 7/27//2010 Class ll: PRODUCT UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with DxI System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations...Read More

Company: Haag-Streit USA Inc. Date of Enforcement Report 7/21//2010 Class ll: PRODUCT Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of Intraocular Lens for implantation after removal of the natural crystalline lens following cataract removal. Recall # Z-1897-2010. REASON...Read More

Company: Bio-Rad Laboratories, In Date of Enforcement Report 7/21//2010 Class ll: PRODUCT 1) VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobin in whole blood. Recall # Z-1901-2010; 2) VARIANT II TURBO Hemoglobin...Read More

Company: Alcon Laboratories Date of Enforcement Report 4/30//2010 Class l: PRODUCT CONSTELLATION Vision System REASON Alcon initiated the recall after it identified both software and hardware problems which have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. These events may cause...Read More

/docs/FDA-HHE-Form0710-UCM126211.pdfRead More

Company:FHC, Inc,.Date of Enforcement Report 6/30//2010 Class ll: PRODUCT FHC micro Targeting Guideline 4000 version 1.4 (GL4K) Software, Catalog # MT-GL4K. Int. This version of software was released in August 2009. Recall # Z-1143-2010 REASON The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to...Read More

Company:PerMedics, Inc.,.Date of Enforcement Report 6/23//2010 Class ll: PRODUCT Odyssey Intended use: Radiation treatment planning system. Recall # Z-1609-2010 REASON Anomaly 1, Invalid Characters in Patient ID Error: Currently, Odyssey considers a valid ID to be comprised of numbers and/or letters. If a patient ID in a study contains a character other than a letter...Read More

Company:Abbott Laboratories, IncDate of Enforcement Report 6/15//2010 Class:ll PRODUCT ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. The Abbott ARCHITECT System is designed to perform automated:...Read More

Company:Mckesson Medical ImagingDate of Enforcement Report 6/15//2010 Class:ll PRODUCT Voiceware clip software update to certain Horizon Medical Imaging Systems. 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 # Z-1735-2010 REASON Voice Clip issue: When the user is...Read More

Recipient: OptoviIe, Inc.. Product: RTVue Optical Coherence Tomography (OCT) with the Normative Database (NDB) Date: 6/11/10 Our inspection revealed your device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C....Read More

Company:GE Healthcare LLC.Date of Enforcement Report 6/9/2010 Class:ll PRODUCT GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic...Read More

Company:GE Healthcare LLC.Date of Enforcement Report 6/2/2010 Class:ll PRODUCT 1) GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ, Cardiovascular Imaging System (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1659-2010; 2) GE Healthcare, Innova 3100 IQ: GE Innova 3100...Read More

Company:Vital Images, Inc.Date of Enforcement Report 5/26//2010 Class:ll PRODUCT Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. Recall # Z-1600-2010 REASON Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea...Read More

Company:Animas Corp.Date of Enforcement Report 5/26//2010 Class:lll PRODUCT One Touch Ping Insulin Pump using ezManager Max diabetes management software. Recall # Z-1560-2010 REASON Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food...Read More

This SoftwareCPR.com newsletter lists items added to the website from Nov 9, 2009 to May 19, 2010 . 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:ZOLL Medical Corp.Date of Enforcement Report 5/19//2010 Class:ll PRODUCT ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Recall # Z-1547-2010 REASON Device issued Shock Advised message but failed...Read More

Company:Optovue Inc.Date of Enforcement Report 5/12//2010 Class:ll PRODUCT Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher. The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an...Read More

CompanyCarefusionDate of Enforcement Report 4/28//2010 Class:ll PRODUCT NicoletOne vEEG System. Recall # Z-1256-2010 REASON CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. The field correction involves providing users with instructions for removing the subject protocols and verifying the deletion has...Read More