Devices

Device Recall BrightView SPECT

  • 모델명 / 제조번호(시리얼번호)
    Model #: 882480; Serial #s: 466, 4000031, 4000048, 4000077, 4000132, 4000186, 4000251, 4000296, 4000323, 4000336, 4000381, 4000390, 4000403, 4000404, 4000405, 4000406, 4000407, 4000414, 4000415, 4000417, 4000418, 4000419, 4000420, 4000421, 4000423, 4000424, 4000425, 4000426, 4000428, 4000429, 4000430, 4000432, 4000434, 4000435, 4000436, 4000437, 4000438, 4000439, 4000440, 4000441, 4000442, 4000443, 4000444, 4000445, 4000446, 4000447, 4000448, 4000449, 4000450, 4000451, 4000452, 4000453, 4000454, 4000455, 4000456, 4000459, 4000460, 4000461, 4000462, 4000463, 4000464, 4000466, 4000467, 4000468, 4000469, 4000470, 4000473, 4000474, 4000475, 4000476, 4000477, 4000478, 4000479, 4000480, 4000481, 4000482, 4000483, 4000486, 4000487, 4000488, 4000489, 4000490, 4000491, 4000492, 4000493, 4000494, 4000495, 4000496, 4000497, 4000498, 4000499, 4000500, 4000501, 4000502, 4000503, 4000504, 4000505, 4000506, 4000507, 4000510, 4000511, 4000513, 4000516, 4000517, 4000518, 4000519, 4000520, 4000521, 4000522, 4000523, 4000524, 4000525, 4000526, 4000527, 4000528, 4000529, 4000530, 4000531, 4000532, 4000533, 4000534, 4000535, 4000536, 4000537, 4000538, 4000539, 4000540, 4000541, 4000542, 4000543, 4000544, 4000546, 4000547, 4000549, 4000550, 4000551, 4000552, 4000553, 4000554, 4000555, 4000556, 4000557, 4000559, 4000560, 4000561, 4000562, 4000563, 4000564, 4000565, 4000566, 4000567, 4000568, 4000569, 4000571, 4000572, 4000573, 4000574, 4000575, 4000576, 4000577, 4000578, 4000579, 4000580, 4000581, 4000582, 4000583, 4000584, 4000585, 4000586, 4000587, 4000588, 4000589, 4000590, 4000591, 4000592, 4000593, 4000594, 4000595, 4000596, 4000597, 4000598, 4000599, 4000600, 4000601, 4000602, 4000603, 4000604, 4000605, 4000606, 4000607, 4000608, 4000609, 4000610, 4000611, 4000612, 4000613, 4000614, 4000615, 4000616, 4000617, 4000619, 4000620, 4000621, 4000622, 4000623, 4000625, 4000626, 4000627, 4000628, 4000629, 4000630, 4000631, 4000632, 4000633, 4000634, 4000635, 4000636, 4000638, 4000639, 4000640, 4000642, 4000643, 4000644, 4000645, 4000646, 4000647, 4000648, 4000649, 4000650, 4000653, 4000654, 4000655, 4000656, 4000657, 4000658, 4000659, 4000660, 4000661, 4000662, 4000663, 4000664, 4000666, 4000667, 4000668, 4000669, 4000670, 4000671, 4000672, 4000673, 4000674, 4000675, 4000676, 4000677, 4000678, 4000679, 4000680, 4000681, 4000683, 4000684, 4000685, 4000686, 4000689, 4000690, 4000692, 4000693, 4000694, 4000695, 4000696, 4000697, 4000698, 4000699, 4340004, 6000102, 40005005, 40007020002, 4000472A & 4000484A.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • 제품 설명
    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
  • 1 Event

제조사

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall BrightView SPECT
  • 모델명 / 제조번호(시리얼번호)
    4000008, 4000287, 4000497, 4000364, 4000346, 4000557, 4000423, 4000088, 4000029, 4000631, 4000339 , 4000072, 4000643, 4000640, 4000420, 4000543, 4000010, 4000282, 4000216, 4000415, 4000208, 4000322, 4000406, 4000434, 4000241, 4000055, 4000117, 4000200, 4000138, 4000352, 4000509, 4000362, 4000598, 4000433, 4000178, 4000473, 4000271, 4000357, 4000258, 4000060, 4000528, 4000099, 4000192, 4000079, 40000101, 4000310, 4000214, 4000671, 4000050, 4000349, 4000658, 4000308, 4000215, 4000384, 4000263, 4000074, 4000255, 4000633, 4000098A, 4000251, 4000446, 4000680, 4000095, 4000424, 4000508, 4000603, 4000347, 4000113, 4000668, 4000703001, 4000140, 4000367, 4000037, 4000426, 4000440, 4000391, 4000177, 4000482, 4000162, 4000083, 4000501, 4000505, 4000317, 4000174
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution - US including AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI, and WV. Internationally to Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, India, Israel, Italy, Japan, Mexico, Republic of Korea, Malaysia Netherlands, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, UAE, and UK. There are eleven (11) government accounts for this recall: Edward Hines Jr VA Hospital, 5th Ave & Roosevelt Rd, Hines, IL 60141; VA Jessie Brown OPC, 2030 W Taylor St, Chicago, IL 60612; VA Medical Center, 4300 W 7th St, Little Rock, AR 72205; VA Medical Center, 2200 SW Gage Blvd, Topeka, KS 66622; VA Medical Center, 2501 W 22nd St, Sioux Falls, SD 57105; VA Medical Center, 3600 30th St, Des Moines, IA 50310; VA Medical Center, 2300 Ramsey St, Fayetteville, NC 28301; VA Medical Center Durham, 508 Fulton St, Durham, NC 27705; VA Medical Center of Orlando, 13800 Veterans Way, Orlando, FL 32827; Veterans Hospital, 1 Veterans Dr, Minneapolis, MN 55417; Womack Army Medical Center, Reilly Rd, Fort Bragg, NC 28307. There are thirteen (13) Canada accounts for this recall: CAMPHILL SITE, 1796 SUMMER ST, HALIFAX, NOVA SCOTIA B3H 3A7; COR CARE INC, 325 MILNER AVE STE 410, SCARBOROUGH, ONTARIO M1B 5N1; CSSS DE RIMOUSKI-NEIGETTE, ROUL¿AU 150, RIMOUSKI, QUEBEC G5L 5T1; FOOTHILLS MEDICAL CENTRE, 1403 29 ST NW, CALGARY, ALBERTA T2N 2T9; HEADWATERS HEALTH CENTRE, 100 ROLLING HILLS DR, ORANGEVILLE, ONTARIO L9W 4X9; HEALTH SCIENCES NORTH, 41 RAMSEY LAKE RD, SUDBURY, ONTARIO P3E 5J1; MEDICAL IMAGING CONSULTAN, 200 BOUDREAU RD STE 102 ST., ALBERT, ALBERTA T8N 6B9; NORTH BAY REGIONAL HEALTH, 50 COLLEGE DR, NORTH BAY, ONTARIO P1B 0A4; PETERBOROUGH REGIONAL HEA, 1 HOSPITAL DR, PETERBOROUGH, ONTARIO K9J 7C6; ROCKY VIEW GENERAL HOSPIT, 7007 14 ST SW, CALGARY, ALBERTA T2V 1P9; ROYAL VICTORIA HEALTH CEN, 201 GEORGIAN DR, BARRIE, ONTARIO L4M 6M2; SOUTHERN ALBERTA INS. TEC, 1301 16 AVE NW, CALGARY, ALBERTA T2M 0L4; WOODSTOCK HOSPITAL, 310 JULIANA DR, WOODSTOCK, ONTARIO N4V 0A4. There is one (1) Mexico account for this recall: Arrendadora Medica Galena, AV Tulum#MZ 1LT 1#SM 12, Benito Juarez, Quintana Roo, 77505.
  • 제품 설명
    BrightView SPECT model number 882480 || BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc