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: 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: 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: 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

Company: Illumina, Inc.Date of Enforcement Report: 9/17/2014 Class lI: PRODUCT Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and...Read More

/docs/scpred/SoftwareCPR-Sept2014Newsletter.pdfRead More

Company: Radiometer America Inc..Date of Enforcement Report: 9/17/2014 Class lI: PRODUCT RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data. Recall Number Z-2597-2014 REASON No reason...Read More

Company: GE Healthcare Date of Enforcement Report: 9/17/2014 Class lI: PRODUCT CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450,...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 9/17/2014 Class lI: PRODUCT Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Recall Number Z-2292-2014 REASON It was discovered that during a RAD examination using Siemens Luminos...Read More

Company: Ab SciexDate of Enforcement Report: 9/17/2014 Class lI: PRODUCT AB SCIEX API 3200MD” LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543. Recall Number Z-2609-2014 REASON Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may...Read More

The link provided is to FDA’s relatively new webpage related to connected health, including cybersecurity, Health IT, Mobile Medical Apps (MMA), and wireless medical devices. The MMA page provides lists of examples of types of MMApps and how they are or are not regulated. https://www.fda.gov/medicaldevices/digitalhealth/Read More

http://www.fda.gov/MedicalDevices/ScienceandResearch/MedicalDeviceDevelopmentToolsMDDT/Read More

Company: Roche Diagnostics Operations, Inc.Date of Enforcement Report: 9/10/2014 Class lI: PRODUCT Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data. Recall Number Z-2563-2014 REASON It has been internally found that if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that...Read More