Devices

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
1 Event
- Recall of Device Recall INTEGRIS BH5000

Manufacturer

Philips Electronics North America Corporation

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

One device with a similar name

Learn more about the data here

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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