Since being introduced, test automation continues to evolve as new technologies are created and released.  One such evolution is Ranorex Online which has been officially released for public beta testing.  Those familiar with test automation are aware that browser plugins are a necessary evil for any web-based testing framework.  Ranorex Online attempts to eliminate that...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 1/11/2017 Class lI: PRODUCT Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior Recall Number Z-1017-2017 REASON This recall has been initiated due to an issue related to the potential accidental...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 1/11/2017 Class lI: PRODUCT DR Systems Unity PACS software, now known as Merge Unity PACS software. Recall Number Z-0939-2017 REASON The software fails to associate to the correct MG image if there are two images for the same view. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on...Read More

What the 21st Century Cures Act Means for Software Manufacturers The 21st Century Cures Act (“Cures Act”), was signed into law by the President on December 13, 2016 (Public Law No. 114-255). This article focuses on section 3060 of the new law; namely “Clarifying Medical Software Regulation.” Other sections of the act address medical devices...Read More

FDA issued a safety notice: Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter.Read More

Hyman, Phelps & McNamara posted a great summary of the impact of the 21st Century Cures Act in regards to general provisions affecting medical device regulation. They also provide links to summaries of other provisions of the act for standalone software (also posted on softwarecpr.com), and drugs and biologics impact.Read More

The law firm of Hyman Phelps and McNamara posted their summary of the impact on this Dec 13, 2016 US Law the 21st Century Cures Act. at the link provided. Section 3060 addresses standalone software and exempts some software from regulation as a medical device. They also provide links to summaries of other provisions of...Read More

The FDA webpage with a summary of how medical device recalls are handled and how FDA may notify the public is at the link provided. This includes examples of types of recall actions. We post software-related recalls on this website and SoftwareCPR can provide expert assistance in compliance with 21 CFR Part 806 Corrections and...Read More

http://blogs.fda.gov/fdavoice/index.php/2016/12/managing-medical-device-cybersecurity-in-the-postmarket-at-the-crossroads-of-cyber-safety-and-advancing-technology/Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/28/2016 Class lI: PRODUCT Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.. Recall Number Z-0878-2017 REASON Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis...Read More

Company: Radiometer America Inc.Date of Enforcement Report 12/28/2016 Class lI: PRODUCT AQURE System Software Version 2.2.0Model #: 933-599UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report 12/28/2016 Class lI: PRODUCT Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable...Read More

/docs/scpred/FDAFInalGuidanceBenefitRiskinDeviceAvailability1216.pdfRead More

Company: Olympus Corporation of the Americas Date of Enforcement Report 12/21/2016 Class lI: PRODUCT HF Cable WA00014A, Endoscopic electrosurgical unit and accessories Recall Number Z-0754-2017 REASON Software malfunction that results in incorrect generation or display of error codes. RECALLING FIRM/MANUFACTURER Olympus Corporation of the Americas, Center Valley, PA on 11/3/2016. Voluntary: Firm Initiated recall is...Read More

Company: Beckman Coulter Inc.Date of Enforcement Report 12/21/2016 Class lI: PRODUCT MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. Recall Number Z-0768-2017 REASON Beckman Coulter has received and...Read More

/docs/scpred/SoftwareCPR-NewsletterDec2016.pdfRead More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/21/2016 Class lI: PRODUCT Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured reporting, text files or...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/21/2016 Class lI: PRODUCT Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Ingenuity Core 128 728323 Computed Tomography X-ray systems Recall Number Z-0696-2017 REASON Software error due to the filament on timer. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH on 11/12/2016. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 509...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report 12/14/2016 Class lI: PRODUCT Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-0720-2017 REASON An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report 12/14/2016 Class lI: PRODUCT RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning SystemProduct Usage:RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. Recall Number Z-0726-2017 REASON Cut lines on the image may present horizontally rather than...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Ingenuity Core 728321 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 equipment supports, components,...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Brilliance 64 728231 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 equipment supports, components,...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 12/14/2016 Class lI: PRODUCT SOMATOM Force, System x-ray, tomography, computed Recall Number Z-0962-2017 REASON Siemens is providing software update versionVA50A_SP3 to address the software bugs thatwere identified through normal field monitoringand the Global Complaint Handling Process.Correction for the problems are as follows:1. Correction to volumetricmisrepresentations...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Brilliance 64 728232 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 equipment supports, components,...Read More

Company: SynCardia Systems Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 Recall Number Z-0659-2017 REASON The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Ingenuity CT 728326 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 equipment supports, components,...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. Recall Number Z-0723-2017 REASON Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/7/2016 Class lI: PRODUCT Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications Recall Number Z-0664-2017 REASON Communication protocols interfacing with the affected software version with some select instruments were not properly...Read More

Company: Elekta, Inc. Date of Enforcement Report 12/7/2016 Class lI: PRODUCT Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-0660-2017 REASON Incorrect Dose when using the reset function. RECALLING FIRM/MANUFACTURER Elekta, Inc., Atlanta, GA on 11/25/2016 Voluntary: Firm Initiated recall is ongoing. VOLUME OF...Read More

“IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved and released. It can be purchased from the ISO at the link provided. This standard addresses Health Software Products in general and does not attempt to define which are regulated and which are not. Its scope is all standalone software...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/7/2016 Class lI: PRODUCT Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the...Read More

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm528236.htmRead More

Zyno Medical LLCProduct: infusion pumps Date:12/5/2016 Failure to establish and maintain procedures to control product that does not conform to specified requirements, and to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). For example: Your firm did not open a non-conforming report (NCR) on 7/30/15, when...Read More

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517526.htmRead More

Company: Merge Healthcare, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT MergeMerge LIS software Recall Number Z-0399-2017 REASON There is a potential for duplicate container numbers to be created for patients.. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 11/11/2016. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 413 sites potentially...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/23/2016 Class lI: PRODUCT SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/23/2016 Class lI: PRODUCT SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different...Read More

Company: Mevion Medical Systems, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT MEVION S250 Product Usage: Proton Radiation Therapy System Recall Number Z-0411-2017 REASON Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with...Read More

Company: Sorin Group USA, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients. Recall Number Z-0413-2017...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. Recall Number Z-0599-2017 REASON The software did not show unviewed images when...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT MergeMerge LIS software Recall Number Z-0611-2017 REASON Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 11/17/2016. Voluntary: Firm Initiated recall is ongoing....Read More

Company: Roche Diabetes Care Date of Enforcement Report 11/23/2016 Class lI: PRODUCT Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 Recall Number Z-0586-2017 REASON Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/23/2016 Class lI: PRODUCT SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different...Read More

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Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report 11/16/2016 Class lI: PRODUCT Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer...Read More