Device Recall INTEGRIS BH5000

  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    INTEGRIS BH5000; Model Number: 72247 || 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 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    FCO 72200129 for 1st phase FCO 72200137 or 72200140 or 72200138 or 72200141 for 2nd phase Equipment #'s 33290, 76992, 103526, 103581, 103921, 104020, 104021, 104068, 104386, 104628, 104926, 104959, 105184, 105399, 105581, 105585, 105654, 504655, 504733, 504742, 504779, 504868, 504903, 504921, 505067, 505068, 505120, 505356, 505380, 505530, 505611, 505703, 506008, 506026, 506069, 506509, 506655, 519118, 519136, 519196, 519197, 519678, 519730, 519981, 520582, 520666, 520688, 520756, 520949, 520964, 521149, 521325, 521525, 522136, 522456, 530396, 530654, 530660, 531649, 531758, 531799, 531939, 532152, 532218, 532240, 532241, 532383, 533288, 534786, 535345, 535761, 535775, 537175, 537593, 538172, 549832, and 44147585.   Additional Equipment #s from Phase 2 - 6967, 10329, 13290, 13294, 13511, 13992, 13993, 14021, 17500, 17626, 25974, 25992, 26064, 35437,, 35485, 37908, 38017, 38028, 38062, 38109, 38329, 38426, 38790, 38792, 38933, 41050, 41080, 41115, 41129, 41340, 41355, 41411, 41423, 41455, 41458, 44714, 44719, 47106, 47127, 50375, 50388, 50392, 50419, 52465, 52470, 52488, 59390, 59418, 59422, 62508, 62519, 62531, 62559, 62606, 62671, 62775, 62776, 62779, 62792, 62806, 62968, 62998, 68255, 76198, 76365, 76395, 76460, 76560, 76572, 76580, 76941, 76953, 82519, 82521, 82608, 82609, 82663, 82709, 83311, 83327, 83823, 83834, 83927, 84469, 84487, 84734, 84827, 85018, 85095, 85150, 85497, 86087, 86415, 86419, 86992, 87068, 87186, 100641, 102523, 102790, 102949, 103003, 104388, 250073, 520720, 542784, 557725, 557726, 557738, 557740, 557761, 557762, 557767, 557770, 557773, 557957, 558028, 558180, 558183, 558287,49788214, 49788954, and 49794641.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Integris BH5000
  • Manufacturer