Devices

Integris BH5000

  • Model / Serial
    Devices are identified with Site Numbers:  103581, 105399, 104386, 105184, 105585, 104021, 105581, 505120, 104020, 504733, 505067, 104068, 504868, 504921, 504674, 505068, 504903, 104628, 105654, 505530, 505703, 505380, 504655, 104926, 504779, 506026, 505611, 506069, 506119, 504742, 104497, 506008, 505903, 506655, 103921, 531926, 519136, 505356, 104950, 519118, 103526, 104953, 104953, 519730, 520949, 520275, 104959, 76992, 520582, 519981, 521525, 519196, 521325, 521149, 522456, 506509, 520688, 44147585, 530653, 531939, 530654, 522136, 520666, 530660, 520964, 532383, 531649, 531799, 532218, 532152, 520756, 533290, 532240, 530396, 532241, 534131, 531758, 534786, 535761, 535775, 519197, 548140, 537175, 533288, 535345, 537593, 538172, and 534156.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    Philips Integris BH5000 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet). || Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips
  • 1 Event

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

Device Recall INTEGRIS BH5000
  • Model / Serial
    All serial numbers
  • Product Classification
    Radiology Devices
  • 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
    Philips Electronics North America Corporation
INTEGRIS BH5000 CARDIOLOGY IMAGING SYSTEM
  • Model / Serial
    Model Catalog: 722021 (Lot serial: ); Model Catalog: (Lot serial: ); Model Catalog: 722042* (Lot serial: N/A); Model Catalog: ALLURA XPER FD10 (Lot serial: ); Model Catalog: 722016 (Lot serial: ); Model Catalog: 722017 (Lot serial: ); Model Catalog: 722041* (Lot serial: N/A); Model Catalog: 722044* (Lot serial: ); Model Catalog: 722043* (Lot serial: )
  • Product Description
    INTEGRIS BH5000 CARDIOLOGY IMAGING SYST
  • Manufacturer
    PHILIPS ELECTRONICS LTD.
Device Recall Integris BH5000
  • 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
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Integris BH5000
  • Manufacturer
    Philips Medical Systems North America Co. Phillips