Company:Roche Diagnostics CorporationDate of Enforcement Report 2/7/2018 Class lI: PRODUCT cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 – cobas e 411 analyzer (disk system) and 04775201001/04775201973 – cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 2/7/2018 Class lI: PRODUCT Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the...Read More

Company:Roche Diagnostics CorporationDate of Enforcement Report 2/7/2018 Class lI: PRODUCT Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 – Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 – Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 – Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative...Read More

Company:Edwards Lifesciences, LLCDate of Enforcement Report 27/2018 Class lI: PRODUCT Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards...Read More

Company:Carl Zeiss Metrology IncDate of Enforcement Report 2/7/2018 Class lI: PRODUCT Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal. Recall Number Z-0379-2018 REASON Due to a software error, it was observed that when the user closes the access door, the system will resume...Read More

Company:Medtronic Inc., Cardiac Rhythm and Heart FailureDate of Enforcement Report 1/31/2018 Class lI: PRODUCT MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data...Read More

Company:Medtronic Inc., Cardiac Rhythm and Heart FailureDate of Enforcement Report 1/31/2018 Class lI: PRODUCT MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device Recall Number Z-0400-2018 REASON Patients monitored on two (2) or...Read More

Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 1/31/2018 Class lI: PRODUCT Brilliance iCT – Model 728306 Computed Tomography X-ray systems Recall Number Z-0403-2018 REASON Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image...Read More

Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 1/31/2018 Class lI: PRODUCT Brilliance iCT SP – Model 728311 Brilliance iCT – Model 728306 Computed Tomography X-ray systems Recall Number Z-0402-2018 REASON Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 1/31/2018 Class lI: PRODUCT Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning. Recall...Read More

The FDA published the guidance document “Refuse to Accept Policy for 510(k)s.” This supersedes the original, issued on August 4, 2015. This revision provides for additional requirements to better ensure substantive content, not just administrative elements that are checked in the initial 15 day refuse to accept initial review. Refuse to Accept Policy for 510(k)sRead More

Company:Phadia US Inc.Date of Enforcement Report 1/24/2018 Class lI: PRODUCT Phadia 1000 Instrument, Article Number 12-3800-01.. Recall Number Z-0387-2018 REASON The “Retry” command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results RECALLING FIRM/MANUFACTURER Phadia US Inc, Portage, MI. on 7/5/2017. Voluntary firm...Read More

Company:RAYSEARCH LABORATORIES AB. Date of Enforcement Report 1/24/2018 Class lI: PRODUCT RayStation Product Usage: 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 be used to administer treatments after review and...Read More

Company:OrthoScan IncDate of Enforcement Report 1/17/2018 Class lI: PRODUCT Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.. Recall Number Z-0258-2018 to Z-0261-2018 REASON OrthoScan Inc. discovered during investigation of a...Read More

The U.S. Food and Drug Administration released the immediately-in-effect (IIE) guidance document, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The guidance lists and explains several key elements of FDA’s enforcement discretion policy, including the Agency’s intention to not enforce standard date formatting, labeling, and GUDID data submission requirements for...Read More

Company:Invivo CorporationDate of Enforcement Report 12/27/2017 Class lI: PRODUCT Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.. Recall Number Z-0263-2018 REASON Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results....Read More

The U.S. Food and Drug Administration issued a Federal Register notice with a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting...Read More

The U.S. Food and Drug Administration issued a Federal Register notice with a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting...Read More

A draft of a new revision of the NIST Framework for Improving Critical Infrastructure Cybersecurity has been circulated for comment.  This draft (NIST_cybersecurity_framework-v1-1) revision refines, clarifies, and enhances Version 1.0 issued in February 2014.  This is a draft for comment. See copy of draft Framework for Improving Critical Infrastructure Cybersecurity Version 1.1Read More

Today the FDA is announcing the availability of the updated final guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways”. This guidance was updated and replaces the Jan 2017 version to include new mechanisms to request (1) a different classification for an existing accessory type (i.e., accessories already on the market), and (2) for...Read More

Company:Normand InformatiqueDate of Enforcement Report 12/20/2017 Class lI: PRODUCT Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta...Read More

Company:Radiometer America Date of Enforcement Report 12/20/2017 Class lI: PRODUCT ABL800 analyzer with FLEXQ module.Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) – in...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report 12/20/2017 Class lI: PRODUCT enGen Track System with TCAutomation Software Version 4.2 Recall Number Z-0254-2018 REASON A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN...Read More

Product: drug manufacturing facilityRead More

FDA issued its list of planned Medical Device Guidance development for 2018. This list has 2 parts: priority development referred to as the A-List and other development referred to as B-list.. Note that FDA does not commit to accomplishing all items on either list; it is just stating its current intention. The A-List includes a...Read More

Company:Roche Diabetes Care, Inc.Date of Enforcement Report 12/13/2017 Class lI: PRODUCT Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood...Read More

Company:GE Medical Systems Information Technologies, Inc.Date of Enforcement Report 12/13/2017 Class lI: PRODUCT CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier softwareThe PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care...Read More

Company:ICU Medical IncDate of Enforcement Report 12/13/2017 Class lI: PRODUCT ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers:(a) 16037-64-01; MedNet 6.1b) 16037-64-02; MedNet 6.1c) 16037-64-03; MedNet 6.1d) 16037-64-04; MedNet 6.21The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion...Read More

On Dec. 8, 2017, the FDA released the draft guidance, “Clinical and Patient Decision Support Software.” This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the...Read More

On Dec. 8, 2017, the FDA released the final guidance, “Software as a Medical Device (SAMD): Clinical Evaluation.” The October 14, 2016, draft is now obsolete. This guidance is actually the use of an International Medical Device Regulators Forum (IMDRF) document completed in June of 2017, so this represents broad international consensus. This guidance discusses...Read More

On Dec. 8, 2017, the FDA released draft guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.” This guidance discusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...Read More

On Dec. 8, 2017 FDA released a Draft guidance “Clinical and Patient Decision Support Software”. This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the definition...Read More

On Dec. 8, 2017 FDA released a Draft guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”. This guidance dsicusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...Read More

On December 7, 2017, FDA Commissioner Scott Gottlieb, M.D., released the statement, “Advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation.” This statement announces the release of several new draft and final guidances as part of the FDA’s Health Innovation Action Plan published previously. The new guidances are posted separately...Read More

Earlier this year FDA released the DH Action Plan, initiating several new guidances, policy changes, and its pre-certification program. Note: Information on the pre-certification program progress during 2017 and release of new guidance (December 2017) is posted separately.Read More

Company:Volcano Corp.Date of Enforcement Report 12/6/2017 Class lI: PRODUCT Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 12/6/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 12/6/2017 Class lI: PRODUCT Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Recall Number Z-0177-2018 REASON A design change was...Read More

Company:BRAINLAB AGDate of Enforcement Report 12/6/2017 Class lI: PRODUCT BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear...Read More

An excerpt of the Medical Device Innovations Section of the US Law PLAW-114Publ255 referred to as the “21st Century Cures Act” and published in December of 2016 is at the link provided. There are many important elements of this law, including how accessories are classified and what software functions are not outside the definition of...Read More

The FDA maintains a dedicated webpage to provide ongoing information on FDA’s digital health initiative.Read More

Company:Spacelabs Healthcare, Ltd.Date of Enforcement Report 11/29/2017 Class l: PRODUCT Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 11/29/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8. Recall Number Z-0115-2018 REASON Potential for software to change the final tool orientation for the command position without command. RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc.Warsaw, IN on 4/8/2016. Voluntary firm initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 64 units DISTRIBUTION...Read More

CompanySiemens Medical Solutions USA, IncDate of Enforcement Report 11/29/2017 Class lI: PRODUCT Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Recall Number Z-0168-2018 REASON Siemens is releasing a non-medical software application LTA...Read More

Company:3M Company – Health Care BusinessDate of Enforcement Report 11/29/2017 Class lI: PRODUCT 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) Recall Number Z-0114-2018 REASON During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to...Read More

Company:Siemens Medical Solutions USA, Inc..Date of Enforcement Report 11/22/2017 Class lI: PRODUCT Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. Serial Number: 2141,...Read More

Company:Siemens Medical Solutions USA, Inc..Date of Enforcement Report 11/22/2017 Class lI: PRODUCT Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. Serial Number: 2136,...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 11/22/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Recall Number Z-0102-2018 REASON An undetected shift between the information displayed in the navigation software and the actual...Read More

Company:ICU Medical IncDate of Enforcement Report 11/22/2017 Class lI: PRODUCT Plum 360 Infusion System, List number 30010. Recall Number Z-0101-2018 REASON (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the “Paused” state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be...Read More

Want a free Android app as a quick reference to the regulations? Paul Felten of SoftwareCPR has developed a new app just for that purpose. You can find it by searching for “SoftwareCPR” in the Google Play store!  Google Play – SoftwareCPR appRead More