Events

HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system). 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Ultrasound, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    30160
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0178-05
  • 사례 시작날짜
    2004-09-10
  • 사례 출판 날짜
    2004-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-02-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35287
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
  • 원인
    Potential for device to cause burning of the skin.
  • 조치
    On 9/6/04 the firm sent a certified return receipt letter to customers advising of the issue and informing that a service representative will visit to install new software to reduce thermal output.

Device

HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
  • 모델명 / 제조번호(시리얼번호)
    Part # 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)  Site numbers: A42000896, A3B000796, A34000603, A2C000441, A32000483, A33000540, A28000273, A35000637, A35000649, A26000159, A45001061, A28000241, A37000732, A25000143, A35000663, A42000932, A32000505, A42000898, A33000546, A24000084, A26000165, A28000255, A28000266, A28000276, A45001050, A36000692, A45001066, A34000559, A24000052, A32000501, A2C000460, A3C000853, A34000582, A2A000350, A2C000458, A2B000408, A28000277, A27000197, A25000136, A33000550, A34000596, A24000104, A34000621, A33000549, A2B000374, A34000607, A43001003, A28000238, A34000568, A28000275, A36000674, A29000323, A2A000354, A29000318, A29000325, A27000188, A36000678, A28000253, A34000628, A27000204, A3B000804, A36000687, A3C000825, A25000140, A3B000799, A28000267, A2A000335, A2A000353, A31000489, A29000289, A2A000338, A39000780, A26000153, A35000636, A2A000348, A38000760, A42000916, A2B000395, A42000912, A24000101, A36000706, A35000665, A34000629, A42000907, A43001005, A25000131, A27000189, A25000123, A42000889, A2C000438, A2B000420, A28000231, A26000160, A37000735, A32000502, A34000595, A24000067, A42000885, A28000270, A24000054, A2B000358, A39000776, A2C000448, A3C000846, A24000087, A35000659, A2C000455, A39000769, A43001006, A26000161, A24000057, A42000945, A34000589, A37000723, A31000477, A31000488, A2B000411, A2C000440, A2C000452, A2C000456, A31000466, A31000467, A31000479, A31000480, A31000481, A32000509, A26000154, A27000181, A42000925, A33000523, A34000577, A3C000812, A29000290, A31000474, A34000602, A26000157, A2A000349, A42000901, A42000947, A23000047, A36000702, A25000146, A2A000345, A44001022, A28000280, A2C000449, A3C000850, A41000861, A24000060, A2A000330, A42000895, A27000212, A26000170, A27000192, A42000931, A37000738, A26000173, A26000179, A26000178, A29000300, A38000753, A39000783, A24000061, A2A000327, A27000186, A2C000463, A31000478, A2C000446, A31000492, A28000235, A28000229, A25000144, A2B000399, A27000198, A27000202, A2C000445, A34000588, A36000677, A3C000824, A43000982, A2B000365, A36000707, EMO00005, A36000705, 34000623, A26000176, A26000180, A25000106, A25000108, A25000115, A34000565, A34000578, A31000476, A32000504, A36000670, A2B000385, A3B000794, A2A000344, A36000694, A3B000806, A3C000826, A39000767, A42000899, A2C000437, A21000016, A25000118, A2C000444, A38000756, A37000720, A45001058, A37000721, A34000612, A32000490, A28000226, A28000260, A24000077, A25000111, A31000475, A33000534, A24000076, A25000116, A35000652, A31000470, A36000716, A35000630, A44001032, A41000872, A2C000451, A2C000457, A32000498, A29000319, A27000210, A24000051, A31000468, A34000557, A34000567, A3B000802, A42000934, A42000921, A35000650, A27000203, A23000040, A34000563, A21000018, A32000495, A36000717, A39000778, A24000096, A25000126, A26000164, A27000194, A42000893, A42000903, A32000515, A34000615, A34000616, A2C000439, A33000536, A34000587, A34000606, A32000507, A25000137, A24000056, A34000614, A25000133, A44001045, A25000147, A23000042, A35000664, A25000130, A25000148, A32000516, A34000611, A43000995, A37000736, A42000894, A31000482, A2A000331, A32000499, A43000980, A35000654, A44001019, A25000110, A34000556, A35000641, A35000642, A44001027, A44001028, A42000913, A3C000813, A42000928, A45001051, A2B000381, A2B000372, A2C000450, A32000513, A24000073, A3B000790, A34000597, A25000145, A31000493, A28000220, A34000627, A35000669, A28000265, A37000743, A35000645, A27000200, A29000310, A28000247, A26000171, A42000922, A27000184, A34000560, A28000243, A24000055, A35000644, A29000292, A21000015, A33000528, A32000517, A27000211, A28000257, A28000230, A2A000340, A34000599, A28000262, A2C000443, A2C000465, A35000643, A2A000337, A28000250, A31000491
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Units were distributed to medial facilities, hospitals, and veterinarians worldwide. Countries include Africa, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Domican Republic, Ecuador, France, Germany, Greece, Guam, Guatemala, Hungary, India, Israel, Italy, Jordan, Kuwait, Martinique, Mexico, Netherlands, New Zealand, Norway, Phlippines, Portugal, Puerto Rico, Peru, Santa Domingo, Saudia Arabia, Selangor, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Zenica
  • 제품 설명
    HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • 제조사 주소
    Philips Ultrasound, Inc., 22100 Bothell-Everett Hwy., P.O. Box 3003, Bothell WA 98041-3003
  • Source
    USFDA