Seapine Software (seapine.com) which provides a variety of development tools published its 2014 report on the state of software development for medical devices. This report was generated based on input from 500 individuals in the medical device industry. It contains a breakdown of risk management methods used, key documentation challenges, requirements management approaches used, test...Read More

Company: Respironics California Inc. (a division of Philips Healthcare) Date of Enforcement Report 11/19/2014 Class I: Date Recall Initiated: September 17, 2014 PRODUCT Esprit V1000 and V200 Ventilators, Model V1000 and V200, Installed with 3rd Generation Power Supplies, and 3rd Generation Power Supply Repair Part Kits ? See complete listing of serial numbers. Manufactured and...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures....Read More

Company: Integra LifeSciences Corp. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 Recall Number Z-0201-2015 REASON ntegra LifeSciences Corporation received 2 complaints that...Read More

Company:Maquet Cardiovascular Us Sales, Llc. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdfRead More

Company: Beckman Coulter Inc.. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdfRead More

Company: Iba Dosimetry Gmbh. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological. Recall Number Z-0168-2015 REASON Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over...Read More

Company: Smiths Medical ASD, Inc. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 11/6/2014 Class lI: PRODUCT Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data...Read More

Company: Nellcor Puritan Bennett Inc. (dba Covidien LP). Date of Enforcement Report 11/6/2014 Class I: PRODUCT Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations. Recall Number Z-0112-2015 REASON A software issue may lead...Read More

Sherman Eagles of SoftwareCPR® provides the following summary of some key points from FDA’s webinar on their premarket cybersecurity guidance on October 29. In the webinar FDA noted that the Instructions for Use should include what cybersecurity controls are needed in the use environment, but stated that it is not sufficient for a device to...Read More

The FDA held a two day public workshop on Collaborative Approaches for Medical Device and Healthcare Cybersecurity on October 21-22. Documentation on the workshop including the video recording of the workshop can be found at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm412979.htm.Read More

/docs/scpred/SoftwareCPRenhanced-V-Diagram1014.pngRead More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 10/29/2014 Class lI: PRODUCT Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: ” Monitoring the physiological parameters of pregnant women ” Non-invasive monitoring of fetal heart rates and movements. Recall Number Z-0105-2015 REASON Philips Intellivue...Read More

Company:Mindray DS USA, Inc. dba Mindray North America.Date of Enforcement Report: 10/29/2014 Class lI: PRODUCT Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 10/29/2014 Class lI: PRODUCT Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM419468.pdfRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM419468.pdfRead More

FDA CDRH maintains a webpage for De Novo Summaries: Evaluation of Automatic Class III Designation De Novo Summaries. This is for devices that are novel but low to moderate risk ((not ideal for 510(k)s and PMA would be overly burdensome). There are now two options for de novo classification. One is in response to an...Read More

Company:Merge Healthcare, Inc.Date of Enforcement Report: 10/22/2014 Class lI: PRODUCT eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 10/22/2014 Class lI: PRODUCT VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate,...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 10/22/2014 Class lI: PRODUCT VITROS 5600 Integrated System, System Product Code 6802413. 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. Recall Number Z-0078-2015 REASON...Read More

/docs/scpred/AgilePlanning102114.pdfRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418469.pdfRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418205.pdfRead More

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm370879.htmRead More

Company: GE Healthcare Date of Enforcement Report: 10/15/2014 Class lI: PRODUCT GE Healthcare Carescape Patient Data Module Recall Number Z-0060-2015 REASON GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM...Read More

Company: Mckesson Information Solutions LLC.Date of Enforcement Report:10/15/2014 Class lI: PRODUCT McKesson Cardiology” Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. Recall Number Z-0042-2015 REASON Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and...Read More

Company: Baxter Healthcare Corp..Date of Enforcement Report:10/7/2014 Class lI: PRODUCT SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. Recall Number Z-2738-2014 REASON One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014....Read More

Company: Siemens Healthcare DiagnosticsDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based...Read More

Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners 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. This device may include signal analysis and...Read More

Company: Siemens Healthcare DiagnosticsDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be...Read More

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdfRead More

/docs/FDACybersecurityPremarketGuidance1014.pdfRead More

Company: Spacelabs Healthcare Inc.Date of Enforcement Report:10/1/2014 Class lII: PRODUCT Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as...Read More

Company: Celera Corporation.Date of Enforcement Report:10/1/2014 Class lII: PRODUCT ViroSeq HIV-1 Genotyping System v2.0, consisting of ViroSeq HIV-1 Genotyping System v2.0 reagent kit and Genotyping Software v3.0. Also contains ViroSeq HIV-1 Genotyping Software Manual and System v2.0 (3130) Operators Manual Recall Number B-0993-14 REASON ViroSeq HIV-1 Genotyping System v2.0, not meeting labeling claim, was distributed.....Read More

Company: Terumo BCT, Inc.Date of Enforcement Report:10/1/2014 Class lII: PRODUCT TerumoBCT, Lakewood, CO 80215 USA. Catalog No: 6100 Spectra Optia Apheresis System Recall Number B-0995-14 REASON Spectra Optia Apheresis Systems with version 11 software, associated with unexpected behavior regarding rinseback, were distributed. RECALLING FIRM/MANUFACTURER Terumo BCT, Inc., Lakewood, CO on 8/27/2014 Voluntary: Firm Initiated recall...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/1/2014 Class lI: PRODUCT Artis zee and Artis zeego systems. x-ray, angiographic system Recall Number Z-2569-2014 REASON There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances,...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/1/2014 Class lI: PRODUCT The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Recall Number Z-2680-2014 REASON Siemens discovered that an unlikely...Read More

Company: MITSUBISHI HEAVY INDUSTRIES, LTD.Date of Enforcement Report: 9/24/2014 Class lI: PRODUCT VERO (TM) Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall Number Z-2653-2014 REASON Software Anomaly: Due...Read More

Company: Varian Medical Systems, Inc.Date of Enforcement Report: 9/24/2014 Class lI: PRODUCT 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Recall Number...Read More

Company: Biofire DefenseDate of Enforcement Report: 9/24/2014 Class lI: PRODUCT JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing...Read More

Company: Dawning Technologies, IncDate of Enforcement Report: 9/24/2014 Class lI: PRODUCT ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 9/24/2014 Class lI: PRODUCT Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. Recall Number Z-2665-2014 REASON Siemens Healthcare Diagnostics has identified a...Read More

The IMDRF issued “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.” This guidance provides terminology and possible framework for the industry and regulators to work from in discussing and dealing with risk related to standalone software used as a medical device.Read More