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February 10, 2016
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...
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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....
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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...
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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...
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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...
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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,...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS Allura 15-12 (mono); Model Number: 722043 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...
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Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS Allura 15-12 (biplane); Product Code: 722044 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...
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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...
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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...
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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...
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Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20/15; Model Numbers: 722058 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...
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Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20/10; Model Numbers: 722029 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...
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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...
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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...
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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...
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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...
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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.)...
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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...
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http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm484914.pdf
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