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

Company: Elekta Inc.Date of Enforcement Report: 9/10/2014 Class lI: PRODUCT Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given...Read More

Company: Elekta Inc.Date of Enforcement Report: 9/10/2014 Class lI: PRODUCT Focal Sim Product Usage: The FOCAL Workstation will continue to be used for patient contouring and viewing of treatment plan outputs. With this new software it will also be able to perform CT simulations and forward their information to the RTP System for dose calculation....Read More

Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)Date of Enforcement Report: 8/27/2014 Class lI: PRODUCT Vital Sync” VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/27/2014 Class lI: PRODUCT Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426 Recall Number Z-2535-2014 REASON Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress...Read More

Company: Philips Healthcare Informatics, Inc. Date of Enforcement Report 8/27/2014 Class lI: PRODUCT Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. Recall Number Z-2252-2014 REASON A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and...Read More

Company: Ansar Group, Inc.Date of Enforcement Report: 8/27/2014 Class lI: PRODUCT blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of a number of components. The components are the following: 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory...Read More

Company: Invivo CorporationDate of Enforcement Report: 8/27/2014 Class lI: PRODUCT Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures. Recall Number Z-2270-2014 REASON...Read More

Company: Biolase Technology IncDate of Enforcement Report: 8/27/2014 Class lI: PRODUCT WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463. Recall Number Z-2263-2014 REASON Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in...Read More

Company:Intelerad Medical SystemsDate of Enforcement Report: 8/27/2014 Class lI: PRODUCT IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging...Read More

Company: Brainlab AG.Date of Enforcement Report: 8/27/2014 Class lI: PRODUCT Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient’s preoperative or Intraoperative...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 8/20/2014 Class lI: PRODUCT Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/20/2014 Class lI: PRODUCT IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is...Read More

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

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 8/13/2014 Class lI: PRODUCT VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) — 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, ion-selective electrode, and...Read More

/docs/FDAHomeUseDesignConsiderationGuidance0814.pdfRead More

Company: Brainlab AG.Date of Enforcement Report: 8/13/2014 Class lI: PRODUCT ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated....Read More

Company: PerkinElmer Health Sciences IncDate of Enforcement Report: 8/16/2014 Class lI: PRODUCT PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data. Recall Number Z-2166-2014 REASON Potential for demographic information...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 8/13/2014 Class lI: PRODUCT VITROS 3600 Immunodiagnostic System — For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600,...Read More

Company: Mckesson Medical Immaging.Date of Enforcement Report:8/5/2014 Class lI: PRODUCT Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall Number Z-2121-2014 REASON The firm...Read More

/docs/FDADraft510kexemptionsguidanceAug2014.pdfRead More

/docs/FDAFiscalYear2015userFeeRates.pdfRead More

/docs/FDAFiscalYear2015userFeeRates.pdfRead More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/302014 Class lI: PRODUCT Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment...Read More

Company: GE Healthcare Date of Enforcement Report:7/30/2014 Class lI: PRODUCT GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Recall Number Z-2085-2014 REASON GE Healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data...Read More

Company:Hospira Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or...Read More

Company:Philips Ultrasound, Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. Recall Number Z-2109-2014 REASON Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0...Read More

Company:Philips Ultrasound, Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. Recall Number Z-2110-2014 REASON Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0...Read More

Company: GE Healthcare Date of Enforcement Report:7/30/2014 Class I: PRODUCT DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients. Recall Number Z-2068-2014 REASON Failure of the CO2 detector in...Read More

Company: Invacare CorporationDate of Enforcement Report: 7/30/2014 Class lI: PRODUCT MK5 NX Controller–Wheelchair controller Recall Number Z-2091-2014 REASON M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward...Read More

/docs/FDAEvaluatingSubstantialEquivalenceGuidance0714.pdfRead More

Brian Pate of SoftwareCPR® writes: In May 2014, FDA offered further guidance to manufacturers regarding premarket submission information identifying cyber-security risks and hazards associated with their medical devices, and the responsibility for engineering appropriate risk controls to address patient safety and assure proper device performance. FDA encouraged manufacturers to report any cyber-security incidents that may...Read More

Company:Shape Medical Systems, Inc.Date of Enforcement Report: 7/123/2014 Class lI: PRODUCT Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will...Read More

Company:Mindray DS USA, Inc. dba Mindray North America.Date of Enforcement Report: 7/23/2014 Class lI: PRODUCT V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. Recall Number Z-2059-2014 REASON...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 7/23/2014 Class lI: PRODUCT Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of...Read More

Company:Spacelabs Healthcare IncDate of Enforcement Report: 7/23/2014 Class lI: PRODUCT Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. Recall Number Z-2077-2014 REASON...Read More

http://www.advisory.com/Daily-Briefing/2014/07/16/Google-wants-a-piece-of-the-eye-teams-up-with-Novartis-on-smart-contact-lensesRead More

Company:Hospira Inc.Date of Enforcement Report: 7/16/2014 Class lI: PRODUCT GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. Recall Number Z-2031-2014 REASON Through customer complaints, Hospira has...Read More

Company: Focus Diagnostics IncDate of Enforcement Report:6/25/2014 Class lI: PRODUCT Simplexa” Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa” Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/9/2014 Class lI: PRODUCT ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. Recall Number Z-1962-2014 REASON There is a potential measurement error with the Auto-Stats (auto statistics) measurement...Read More

Company: Nihon Kohden America IncDate of Enforcement Report:6/25/2014 Class lI: PRODUCT CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients. Recall Number Z-1979-2014 REASON Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting...Read More

Company:Baxter Healthcare Corp.Date of Enforcement Report: 7/9/2014 Class lI: PRODUCT EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a...Read More