Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications including diagnostics, interventional...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: ” Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well...Read More

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm484914.pdfRead More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS BH5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS...Read More

Company: Philips Medical Systems Date of Enforcement Report 2/10/2016 Class lI: PRODUCT DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 Recall Number Z-0745-2016 REASON In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Mindray DS USA, Inc. dba Mindray North AmericaDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: ” Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography,...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.)...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/102016 Class lI: PRODUCT Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). Recall Number Z-0702-2016...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications including...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). Recall Number Z-0703-2016 REASON The use of Allura Xper, Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications including...Read More

Company: Radiometer America IncDate of Enforcement Report 2/10/2016 Class lI: PRODUCT AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. Recall Number Z-0748-2016 REASON The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results....Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging...Read More

Company: Siemens Healthcare Diagnostics, Inc..Date of Enforcement Report 2/10/2016 Class lI: PRODUCT ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte...Read More

/docs/FDAhighestprioritydevices4humanfactorsreview0216.pdfRead More

/docs/FDA-HFE-UE-FinalGuidance0216.pdfRead More

/docs/FDA-HFE-UE-FinalGuidance0216.pdfRead More

Company: Bio-Rad Laboratories Inc.Date of Enforcement Report 2/3/2016 Class lI: PRODUCT D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data...Read More

NOTE: This is for historical reference as a final guidance was issued Sept 2017 and is posted separately. FDA issued a new draft guidance entitled “Design Considerations and Pre- market Submission Recommendations for Interoperable Medical Devices”. This guidance addresses medical devices that exchange information whether wired or wireless including through the internet. It includes unidirectional...Read More

FDA held a two day public cybersecurity workshop Jan 20-21,2016.   See the output, including links to the webcasts, from the workshop sessions.Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 1/20/2016 Class lI: PRODUCT VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 1/20/2016 Class lI: PRODUCT VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 1/20/2016 Class lI: PRODUCT VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 1/20/2016 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended...Read More

Sherman Eagles of SoftwareCPR expects increased standards and regulatory activity related to Software and HealthIT in 2016. Here are some of the areas to watch: IEC 82304-1 Health Software: General requirements for safety will be completed during the first half of 2016. It is intended that this standard be harmonized in the EU, but it...Read More

Note:  This draft is OBSOLETE and included only for historical reference only.  Look for the final draft elsewhere on this site. To view the guidance click this link:  2016-01-FDA Post market Cybersecurity draft guidance This guidance references a number of Presidential Executive Orders related to critical infrastructure and cybersecurity as a driving force for FDA’s increased oversight...Read More

FDA held a public workshop, “Collaborative Approaches for Medical Device and Healthcare Cybersecurity,” October 21-22, 2014, in partnership with the Department of Homeland Security. The program book issued by FDA after the workshop was held is at the link provided. It contains information on the sessions, objectives, and speaker biographies. Sherman Eagles of SoftwareCPR® was...Read More

Company: Philips Ultrasound Inc Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0) Recall Number Z-0596-2016 REASON Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Oncentra External Beam – VMAT – Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-0604-2016 REASON When...Read More

Company:Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Date of Enforcement Report 1/132016 Class lI: PRODUCT Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks...Read More

Company: Vidco Inc.Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. Recall Number Z-0597-2016 REASON Potential post-processing software issue when using tabcard “4D” on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are...Read More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htmRead More

Company: Merge Healthcare Inc. Date of Enforcement Report 1/6/2016 Class lI: PRODUCT Merge Cardio with software version 10.1 LA. Recall Number Z-0555-20166 REASON The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. RECALLING FIRM/MANUFACTURER Merge Healthcare Inc., Hartland, WI...Read More

Company: Merge Healthcare Inc. Date of Enforcement Report 1/6/2016 Class lI: PRODUCT Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. Recall Number Z-0554-2016 REASON The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/6/2016 Class lI: PRODUCT MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-0557-2016 REASON Incorrect drug dosage...Read More