The pdf at the link provided contains slides from a presentation by Brian Pate providing an overview of the soon to be released “Agile Methods for Medical Device Software Development” Technical Information Report (TIR). These slides focus on the TIR. We have posted another slide set in our library with some training slides on SoftwareCPR...Read More

Company:SIGMA International, LLCDate of Enforcement Report 6/18/12 Date Recall Initiated: July 6, 2011 Class l: PRODUCT SIGMA Spectrum Infusion Pump Model 35700. The SIGMA Spectrum Infusion Pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products through parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration....Read More

Recipient:  Shamrock Medical Solutions Group LLC . Product:  Pharmeceuticals Date: 6/15/2012 Investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of...Read More

Recipient:  American Optisurgical Inc. Product:  TX1 Tissue Removal System Date: 6/14/2012 This 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, their manufacture, packing, storage, or installation are not in conformity...Read More

Company:Philips Medical Systems (Cleveland) Inc.Date of Enforcement Report 6/13/12 Class ll: PRODUCT The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/6/12 Class ll: PRODUCT 1) Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 – ACUSON S2000 Mainframe; The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic...Read More

Company:Becton Dickinson & Co..Date of Enforcement Report 6/6/12 Class ll: PRODUCT 1) Becton Dickinson Phoenix” System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram...Read More

Company:Computerized Medical Systems Inc.Date of Enforcement Report 6/6/12 Class ll: PRODUCT XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within...Read More

Company:Ortho-Clinical Diagnostics.Date of Enforcement Report 6/6/12 Class ll: PRODUCT VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Product...Read More

Company:Philips Healthcare Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital. Model #s 712020, 712022, 712082. Recall # Z-1464-2012 REASON Potential misdiagnosis due to improperly automatically stitched images improper image ruler handling RECALLING FIRM/MANUFACTURER Recalling Firm:...Read More

Company:Siemens Healthcare Diagnostics, Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT Siemens Healthcare Diagnotics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension...Read More

Company:Safe Trace Tx (Horizon Blood Bank, Haemonetics Software SolutionsDate of Enforcement Report 5/30/12 Class ll: PRODUCT SafeTrace Tx, also rebranded as Horizon Blood Bank Haemonetics Software Solutions (formerly Wyndgate Technologies) Recall # B-1434-12 REASON Safe Trace Tx (Horizon Blood Bank, Haemonetics Software Solutions), with a software glitch or defect that could result in an ABO...Read More

Company:Varian Medical Systems, Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall # Z-1175-2012 REASON An...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT ACUSON S1000 ultrasound systems running software version 1.0. The product is indicated for use as an ultrasound imaging system. Recall # Z-1616-2012 REASON When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the...Read More

http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htmRead More

http://1.usa.gov/1j9K0lHRead More

The FCC voted to allocation special seperate wireless spectrum for devices implanted or attached to the the body for monitoring purposes.Read More

Company: Philips Healthcare Inc.Date of Enforcement Report 5/23/12 Class ll: PRODUCT Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital. Model #s 712020, 712022, 712082. Recall # Z-1464-2012 REASON Potential misdiagnosis due to improperly automatically stitched images improper image ruler handling. RECALLING FIRM/MANUFACTURER Recalling...Read More

Company: Varian Medical Systems, Inc.Date of Enforcement Report 5/23/12 Class ll: PRODUCT True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Product Usage: TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Model number H19. Recall...Read More

Company:Fresenius Medical Care Holdings, Inc.Date of Enforcement Report 5/23/12 Class ll: PRODUCT Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius Liberty Cycler is intended for acute or chronic peritoneal dialysis. Product Codes: Cyclers: 180020, 180111 User Manuals: 480001 Handi-Guides: 480017. Recall #...Read More

Company: CaridianBCT Date of Enforcement Report 5/23/12 Class ll: PRODUCT Trima Accel Automated Blood Collection System, catalog number 917000000. Product Usage: Automated Blood Collection System for use in humans. Recall # Z-1541-2012 REASON Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood...Read More

Company: Sandhill Scientific, Inc.Date of Enforcement Report 5/23/12 Class ll: PRODUCT Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders. Recall # Z-1487-2012 REASON Software error may produce...Read More

Company:MVisicu, Inc., .Date of Enforcement Report 5/16/12 Class ll: PRODUCT Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks....Read More

Company:Medical Information Technology, Inc.Date of Enforcement Report 5/16/12 Class ll: PRODUCT MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13 Product Usage: Meditech Anatomical Pathology Software records, stores, codes, searches and provides reports for pathology cases. It enables pathology staff and other personnel...Read More

The Association for the Advancement of Medical Instrumentation (AAMI) is reorganizing its committee structure related to Software, Health IT, networks and related topics by forming a Software and Health Information Technology (SWIT) committee to oversee all related standards activities. The current plan is that this committee will coordinate all work in the Software, IT, MDDS,...Read More

Recipient: BTS S.p.A. Product: FreeEMG and PocketEMG Date: 5/10/2012 This 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, their manufacture, packing, storage, or installation are not in conformity with the...Read More

Company:Varian Medical Systems, Inc.Date of Enforcement Report 5/9/12 Class ll: PRODUCT FastPlan Treatment Planning System, Model HZ3, Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing tablet, and radiation treatment planning application software. Recall # Z-1217-201 REASON An anomaly has been...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109203.pdfRead More

While FDA has oversight over Medical devices for vetinary use they are not treated like devices for human use. Generally a quality system although recommended is not required and unless the device emits radiation registration and listing is not required. Below is an excerpt from the FDA website: How FDA Regulates Veterinary Devices The Federal...Read More

Recipient: Mediagnost GmbH. Product: Human Growth Hormone diagnostic kits Date: 5/8/12 Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40. For example: a. There are no procedures that address the control of electronic records. b. Access to two computer workstations that include in-process test data, finished device...Read More

Company:Ortho-Clinical Diagnostics Date of Enforcement Report 5/2/12 Class ll: PRODUCT 1) VITROS? ECi Immunodiagnostic System, Catalog No. 8633893 — COMMON/USUAL NAME: VITROS? ECi System. All systems that has Software Version 3.8 or below installed and on which the VITROS? Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic...Read More

Company:Viterion HealthcareDate of Enforcement Report 5/2/12 Class ll: PRODUCT 1) Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Product Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis...Read More

Company:Scottcare Corp.Date of Enforcement Report 5/2/12 Class ll: PRODUCT TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01, Part #101086. The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection...Read More

Company:Viterion HealthcareDate of Enforcement Report 5/2/12 Class ll: PRODUCT Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Common Name: Viterion100 TeleHealth Monitor — Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The...Read More

The American College of Clinical Engineering issued its ACCE 2012 Challenge Awards. Sherman Eagles of SoftwareCPR received an award achievement in the field of health technology management for his leadership of the working groups for IEC 80001-1 for risk management of IT networks that incorporate medical devices and the AAMI Medical Device Data System-MDDS/Quality Systems...Read More

Company:Lifescan Inc. Date of Enforcement Report 4/25/12 Class ll: PRODUCT OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. Meter made in China. Intended to be used for the quantitative measurement of glucose in fresh...Read More

Company:Philips Medical Systems Date of Enforcement Report 4/25/12 Class ll: PRODUCT Brilliance Workspace IntelliSpace Portal, M/N 728269, The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device...Read More

Company:Philips Healthcare Inc. Date of Enforcement Report 4/18/12 Class ll: PRODUCT MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This...Read More

Company:Siemens Healthcare Diagnostics, Inc.Date of Enforcement Report 4/18/12 Class ll: PRODUCT EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 4/18/12 Class ll: PRODUCT GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended...Read More

Company:Animas Corp Date of Enforcement Report 4/18/12 Class ll: PRODUCT OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. Part number 101420-00, 10142100, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, 101425-98, and 10050000. Recall # Z-1376-2012 REASON There is an error in the pump...Read More

Company:Baxa Corp. Date of Enforcement Report 4/18/12 Class ll: PRODUCT Pharmacy compounding system. It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients. 2 model numbers 2400 D and 2400 M. Recall #...Read More

Company:Philips Medical Systems Date of Enforcement Report 4/11/12 Class ll: PRODUCT Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model # 728231, Ingenuity CT Model # 728326. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission...Read More

Company:Medtronic Neuromodulation Date of Enforcement Report 4/11/12 Class ll: PRODUCT Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20, 8637-40, N’Vision clinical programmer 8840 and the Software application card 8870. The SynchroMed II Infusion system contains and administers...Read More

/Docs/FDA-513gFinalGuidance040612.pdfRead More

Company:RAYSEARCH Laboratories AB,. Date of Enforcement Report 4/11/12 Class ll: PRODUCT RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. Model RayStation 2.0. Designed for treatment planning and analysis of radiation therapy. Recall # Z-1317-2012 REASON An issue was found with the dose calculation, that could result in a potential overestimation of the dose. This could...Read More

Recipient:Community Blood Centers of Florida, Inc. . Product:blood and blood components Date: 4/7/2012 The Food and Drug Administration (FDA) conducted an inspection of your firm, Community Blood Centers of Florida, Inc., from September 1, 2011 – December 19, 2011. During the inspection, FDA investigators documented deviations from applicable current Good Manufacturing Practice for Finished Pharmaceuticals...Read More

Company:QRS Diagnostic. Date of Enforcement Report 4/4/12 Class ll: PRODUCT QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 4/4/12 Class ll: PRODUCT MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 4/4/12 Class ll: PRODUCT The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray...Read More