Company: Merge Healthcare, Inc. Date of Enforcement Report 3/15/2017 Class lI: PRODUCT Merge Cardio software using EchoIMS Recall Number Z-1415-2017 REASON A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland,...Read More

Company:Medtronic Neuromodulation Date of Enforcement Report 3/8/2017 Class l 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.) Recall Number Z-0788-2017 REASON Medtronic is following...Read More

Company: Mckesson Medical Imaging Date of Enforcement Report 3/8/2017 Class lI: PRODUCT McKesson Radiology 12.2 – Picture Archive Communication System (PACS). Recall Number Z-1245-2017 REASON Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a...Read More

The presention material for the FDA Webinar – Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance – February 23, 2017 is at the link provided. FDA Presentation on Benefit-Risk IDE DevicesRead More

Company: Tosoh Smd Inc Date of Enforcement Report 3/1/2017 Class lI: PRODUCT Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. Recall Number Z-1245-2017...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 3/1/2017 Class lI: PRODUCT Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/1/2017 Class lI: PRODUCT Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI. Recall Number Z-1246-2017 REASON Eye Station images were not importing properly and were imported under...Read More

Company: Denttio, Inc.Product: digital x-ray image receptors and intraoral microscope/cameras Date:2/23/2017 Failure to perform device software validation and risk analysis as required by 21 CFR 820.30(g). For example, you do not have records to demonstrate that your Imaging Software used with the Tio-H Digital X-Ray Sensor has been validated. You do not have records to...Read More

Company: BioMerieux SA Date of Enforcement Report 2/22/2017 Class lI: PRODUCT VIDAS 3 software v. 1.1.4 Recall Number Z-1200-2017 REASON During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field. RECALLING FIRM/MANUFACTURER...Read More

Company: Physio-Control, Inc. Date of Enforcement Report 2/15/2017 Class lI: PRODUCT LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of...Read More

Company: Physio-Control, Inc. Date of Enforcement Report 2/15/2017 Class lI: PRODUCT LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. Recall Number Z-1144-2017 REASON The End-Tidal CO2 (EtCO2) reading can intermittently show a value...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/15/2017 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). Model number 136 T1700 Capture Stations & 46 T5810 Capture Station Recall Number Z-1142-2017 REASON Merge received reports of Merge Eye Station...Read More

Company: Boston Scientific Corporation Date of Enforcement Report 2/152017 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). Model number 136 T1700 Capture Stations & 46 T5810 Capture Station Recall Number Z-1178-2017 REASON There is a potential for radio frequency...Read More

http://www.congress.gov/bill/115th-congress/senate-bill/404/textRead More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/152017 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-1176-2017 REASON Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/152017 Class lI: PRODUCT Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-1180-2017 REASON The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis...Read More

View the english version of the China FDA (CFDA) website.  Formerly the State FDA (SFDA), the CFDA is promoting use of 62304 for medical device software and essentially ISO/IEC 14764 for IT maintenance.  It is also actively expanding its requirements related to cybersecurity of networked devices.Read More

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398226.htmRead More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/8/2017 Class lI: PRODUCT Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation....Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/8/2017 Class lI: PRODUCT Syngo.plaza, picture archiving and communications system. Recall Number Z-1116-2017 REASON Software update for improvements and to resolve several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 1/11/2017 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company: Mevion Medical Systems, Inc.. Date of Enforcement Report 2/8/2017 Class lI: PRODUCT MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy Recall Number Z-1122-2017 REASON An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened RECALLING FIRM/MANUFACTURER Mevion Medical Systems, Inc., Littleton, MA on...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure Recall Number Z-1091-2017 REASON There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Cobas b 123 POC systemThe cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives...Read More

Company: Roche Diabetes Care, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Accu-Chek Connect Diabetes Management App Recall Number Z-1099-2017 REASON iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using...Read More

Company: Soft Computer Consultants, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management,...Read More

Company: Soft Computer Consultants, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.. Recall Number Z-1098-2017 REASON Software error. Potential for...Read More

The U.S. government established the Office of the National Coordinator for Health Information Technology (ONC) in 2004 and increased its role significantly in 2009 to promote and certify certain aspects of Health IT, including electronic medical record systems. Although a voluntary program, certification is required to access a number of financial incentives. This is entirely...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Merge Cardio software. Product Usage: 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...Read More

Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Fresenius 2008T Series Hemodialysis System Recall Number Z-1026-2017 through Z-1029-2017 REASON When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled...Read More

Company: Carestream Health Inc Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body Recall Number Z-1052-2017 REASON Software error; Carestream Health Inc, received a complaint stating that when a user...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 1/25/2017 Class lII: PRODUCT AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process....Read More

Company:Elekta, Inc.Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-1044-2017 REASON Incorrect dose after editing beam number an wedge angle. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta, GA, on 1/10/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...Read More

Company: DICOM GRID INC Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images. Recall Number Z-1045-2017 REASON A software error caused the window/level to become the same in one series regardless if the image had...Read More

Company: Blood Bank Computer Systems, IncDate of Enforcement Report 1/25/2017 Class lI: PRODUCT Blood Bank Control System (BBCS) Primary Application, V 5.4.3, 5.5 is intended to address all phases of donor and transfusion services. The software is also capable of operating with or without ABO QuickPass (BK14130) to allow donors to complete Computer Assisted Self...Read More

Company: Carefusion Date of Enforcement Report 1/25/2017 Class I: PRODUCT Product Description: Alaris Syringe Pump Module (Large Volume Pump), Model No. 8100 and AIL sensor kits Recall number Z-0950-2017 REASON CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump...Read More

Company: The Binding Site Group, Ltd. Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Digital RID Plate Reader and Software Product Code: AD400 Recall Number Z-1055-2017 REASON If a control ring is marked after reading, the software will not flag results that are out of the specified QC range. RECALLING FIRM/MANUFACTURER The Binding Site Group,...Read More

FDA issued a Final guidance entitled: “Postmarket Management of Cybersecurity in Medical Devices”. FDA held a free webinar on this guidance on Jan. 12,2017. Information information and presentation materials are at the link provided. SoftwareCPR can provide expert cybersecurity consulting services for regulatory compliance andrisk analysis, technical threat and vulnerability assessment as well as for...Read More

The FDA issued a draft guidance “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers”. The full draft is at the link provided. Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and AnswersRead More

Company: Toshiba American Medical Systems Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Ultimax DREX-ULT80, Model No. KXO-80XM Multipurpose digital x-ray system for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy Recall Number Z-1022-2017 REASON It has been found that the generator of the system could possibly terminate the exposure prematurely during an examination....Read More

Company:Varian Medical Systems, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-1009-2017 REASON Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. RECALLING FIRM/MANUFACTURER Elekta inc., Atlanta, GA on 12/21/2016. Voluntary: Firm Initiated...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 1/18/20176 Class lI: PRODUCT IQon Spectral CT with software version 4.7.0Product Usage:The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-1006-2017 REASON...Read More

SoftwareCPR has posted its new checklist for “IEC 82304-1: Health software – Part 1: General requirements for product safety” in our website library and on our checklists page. This is free for our paid subscribers. SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device software...Read More

Company: Toshiba American Medical Systems Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Kalare DREX-KL80, Model No. KXO-80XD Diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations Recall Number Z-1021-2017 REASON It has been found that the generator of the system could possibly terminate the exposure prematurely during an...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer. Recall Number Z-0987-2017 REASON Cross profile for Varian 60 degree wedge shows “horns.”...Read More

Company: Morton Grove Pharmaceuticals, Inc. Date:1/17/2017 Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to...Read More

The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics. 21st Century Cures ActRead More

FACTA Farmaceutici S.p.A Product: drug manufacturing facility Date:1/13/2017 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). For multiple sterile drug product lots, your original data showed failing results, but data you reported showed passing results....Read More

The US FDA issued a FINAL guidance entitled: “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions”. This guidance references software features in Appendix C the device description section. The full guidance is at the link provided. FDA FINAL Guidance Benefit-Risk IDE DevicesRead More