Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...Read More

Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...Read More

UL 2900-1 Ed.1 2017 Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements was recognized by FDA on August 21, 2017. See at: FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047.Read More

This SoftwareCPR.com newsletter in .pdf form lists items added to the website from late-April of 2017 through mid-August of 2017. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or...Read More

The FDA published a FAQ for companies that may be interested in participating in the Digital Health Software Precertification Program.Read More

Company:Soft Computer Consultants, Inc.Date of Enforcement Report 8/9/2017 ClasslI: PRODUCT SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, Recall Number Z-2865-2017 REASON Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent...Read More

The FDA held a meeting and webcast regarding initial development of its new approach for Digital Health Regulation. The FDA’s Digital Health Precertification webpage is at the link provided, and the slides from their presentation can be downloaded.Read More

"Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review"Read More

Company:Beckman Coulter Inc.. Date of Enforcement Report 8/2/2017 Class lII: PRODUCT Beckman Coulter PK7300(R) Automated Microplate System, Catalogue Numbers: N3209000 and N2007600y Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number B-0741-2017 REASON Beckman Coulter’s PK7300, associated with a defect or glitch with the dispensing monitoring board, was distributed.. RECALLING FIRM/MANUFACTURER Bedkman Coulter, Brea, CA...Read More

Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 Class lI: PRODUCT CS 100i Intra-Aortic Balloon Pump. Recall Number Z-2736-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a...Read More

Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 ClasslI: PRODUCT CS 300 Intra-Aortic Balloon Pump Recall Number Z-2738-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient...Read More

Company:Medtronic Navigation Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Recall Number Z-2746-2017 REASON Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user...Read More

Company:AGFA Healthcare Corp. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Agfa Healthcare NX 3.0.8950 Imaging Processing Software Recall Number Z-2735-2017 REASON A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server...Read More

Company:Draegar Medical Systems, Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number Z-2734-2017 REASON Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.. RECALLING FIRM/MANUFACTURER Draegar...Read More

FDA issued a new draft guidance entitled”Draft Guidance for Industry; How To Prepare a Pre-Request for Designation”. This guidance is intended to describe informal interaction with FDA that might lead to a formal Designation request to determine wether a product will be regulator as a device or a drug and some combination thereof. The full...Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 7/12/2017 Class lI: PRODUCT Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 — Programmable diagnostic computer, Recall Number Z-2688-2017 REASON Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/...Read More

Company: Ion Beam Applications S.A.. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System – Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation....Read More

Company:CareFusion 303, Inc. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT Alaris PC Unit, Model 8015 Recall Number Z-2671-2017 REASON BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions. RECALLING...Read More

Company: CardioTek BV. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. Recall Number Z-2657-2017 REASON Software bug which allows parameters to be changed unintentionally...Read More

Company: AGFA Healthcare Corp.. Date of Enforcement Report 7/5/2017 Class lI: PRODUCT IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats Recall Number Z-2652-2017 REASON A customer experienced when...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 7/5/2017 Class lI: PRODUCT Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are...Read More

“IEC TR 80002-2 Medical device software – Part 2: Validation of software for medical device quality systems” has been published. This TR provides guidance for new requirements in ISO 13485:2016 for validating software used in quality systems. ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labeling, packaging, distribution and...Read More

SoftwareCPR® – Human Factors and Usability Engineering Assessment Does the design of your device promote safe and effective use? Are you ready for an FDA regulatory submission requiring HFE/UE report? Do you maintain a usability engineering file for your products? Is it complete? Do you have a systematic process for identifying and analyzing use error?...Read More

FDA issues a new draft guidance in June 2017 titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers”.  This guidance while scoped for clinical investigations has information that is probably useful and defensible for assessing or ensuring compliance with other types of systems subject...Read More

FDA CDRHLearn released a new tutorial entitled ‘Electronic Submission of 806 Reports of Corrections and Removals”. The full tutorial is at the link provided. FDA Tutorial E-submission of 806 reportsRead More

Symantec Cybersecurity expert Axel Wirth provided an AAMI podcast presentation June 21, 2017 titled “Patch Management in Healthcare”.  The podcast is on the AAMI page at the link provided along with several other podcasts related to cybersecurity in the prior two episodes.Read More

AAMI Software and IT-related standards working groups include one for interoperability (with 3 standards work items), one for Device Security (with 2 standards work items), one for Wireless, one for SW Defect Classification, and one for AAMI/UL 2800-1 for specification of architecture independent requirements. There is also a separate Health IT Committee with several items...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 6/21/2017 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-2591-2017 REASON Merge PACS did not show unviewed images when the last...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 6/21/2017 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-2590-2017 REASON Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because...Read More

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm563249.htmRead More

http://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/Read More

Company: Circadiance LLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients Recall Number Z-2250-2017 REASON Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to...Read More

Company: Nexstim PLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. Recall Number Z-2319-2017 REASON Software defect: the NBS software may...Read More

Company: Nexstim PLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of...Read More

Company: Toshiba American Medical Systems Inc Date of Enforcement Report 6/7/2017 Class lI: PRODUCT Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F Recall Number Z-2109-2017 REASON It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected...Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 5/31/2017 Class lI: PRODUCT AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.. Recall Number Z-2156-2017 REASON An extremely dusty computer can cause problems at system start, or rarely, cause system fail....Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 5/31/2017 Class lI: PRODUCT Merge Cardio software Recall Number Z-2123-2017 REASON Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother’s MRN, resulting in the wrong fetal measurements getting referenced. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc.,...Read More

Company: Ortho-Clinical Diagnostics. Date of Enforcement Report 5/24/2017 Class lI: PRODUCT enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD Recall Number Z-2077-2017 REASON Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the...Read More

Company: Ion Beam Applications S.A .Date of Enforcement Report 5/24/2017 Class lI: PRODUCT Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Recall Number Z-2097-2017 REASON A PBS (Pencil...Read More

Company: Magellan Diagnostics Inc. Date of Enforcement Report: 5/24/2017 Class I: PRODUCT Magellan Diagnostics Inc. Recalls LeadCare Plus and Ultra Testing Systems Due to Inaccurate Test Results. The LeadCare Plus and the LeadCare Ultra Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a...Read More

Company: Mobius Medical Systems, LP Date of Enforcement Report 5/24/2017 Class lI: PRODUCT Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially...Read More

Company: Abbott-Thoratec Date of Enforcement Report 5/23/2017 Class I: PRODUCT HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller The Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system, a mechanical device that circulates...Read More

FDA, together with the National Science Foundation (NSF) and the Department of Homeland Security Science, and Technology, held a public workshop May 18-19, 2017. Results of this workshop, including webcasts of the sessions, are at the FDA website. Public Workshop – Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis, May 18-19, 2017Read More

Company: Roche Diabetes Care, Inc. Date of Enforcement Report 5/10/2017 Class lI: PRODUCT Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 5/10/2017 Class lI: PRODUCT AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser,...Read More

We help you meet the intent of the rule -- not the hypeRead More

Company: Orthosoft, Inc. dba Zimmer CAS. Date of Enforcement Report 5/3/2017 Class lI: PRODUCT Navitrack System – OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components Recall Number Z-1881-2017 REASON Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System – OS Knee...Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 5/3/2017 Class lI: PRODUCT 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C;Model numbers:18L6 HD transducer  10041227 & 10789400S1000  10441701S2000  10041461S2000 (Refurb) – 10440017S3000  10441730Radiology Recall Number Z-1875-2017 REASON When scanning with the 18L6 HD...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 4/26/2017 Class lI: PRODUCT Merge Eye Station and Merge Eye Care PACS Recall Number Z-1828-2017 REASON During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image...Read More