Events

Mindray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mindray DS USA, Inc. dba Mindray North America 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
    75062
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0321-2017
  • 사례 시작날짜
    2016-09-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149263
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    Mindray has become aware that the td60 display telemetry transmitter used with the benevision central station may crack on the bezel surrounding the display and also the transmitter may not power on or will power on but display an error message.
  • 조치
    Mindray sent a "Medical Device Action" letter dated September 8, 2016 via UPS to their affected customers.

Device

Mindray
  • 모델명 / 제조번호(시리얼번호)
    p/n 115-029485-00, Serial #'s HHA59001430, HHA59001439, HHA59001450 thru HHA59001460, HHA59001537, HHA59001540, HHA59001549 thru HHA59001550, HHA59001591,HHA59001609, HHA59001615, HHA59001626, HHA59001632, HHA5A003110, HHA5A003113 thru HHA5A003115, HHA5A003118 thru HHA5A003119, HHA5C004233, HHA5C004485, HHA59001420 thru HHA59001429, HHA5B003441 thru HHA5B003450, HHA5C004059, HHA5C004065, HHA5C004075, HHA5C004077, HHA5C004091, HHA5C004095 thru HHA5C004097, HHA5C004102, HHA5C004106, HHA57000155 thru HHA57000161, HHA57000163 thru HHA57000168, HHA57000171, HHA57000173 thru HHA57000180, HHA57000182 thru HHA57000184, HHA57000195 thru HHA57000199, HHA57000201 thru HHA57000205, HHA57000207, HHA57000209 thru HHA57000223, HHA58001037, HHA59001386, HHA59001432, HHA5A003075, HHA5A003079, HHA5A003264, HHA5B003365, HHA5B003386, HHA5B003451 thru HHA5B003452, HHA5B003877, HHA5B003880, HHA5C004098, HHA5C004104, HHA5C004110, HHA5C004113, HHA5C004126, HHA5C004134, HHA5C004200, HHA5C004464, HHA5C004470, HHA57000357, HHA57000363 thru HHA57000364, HHA58000631, HHA58000636 thru HHA58000639, HHA58000641, HHA58000858 thru HHA58000868, HHA58000890 thru HHA58000891, HHA58000893, HHA58000897 thru HHA58000906, HHA58000908 thru HHA58000910, HHA58000912 thru HHA58000913, HHA58000916 thru HHA58000918, HHA5800920 thru HHA58000921, HHA58000937, HHA58000957, HHA58000961, HHA58000984, HHA58000986 thru HHA58000997, HHA58000999 thru HHA58001003, HHA58001005 thru HHA58001007, HHA58001009, HHA58001012 thru HHA58001013, HHA58001042 thru HHA58001048, HHA58001052, HHA58001055, HHA5A003071, HHA5A003078, HHA5A003080, HHA5A003085, HHA5A003263, HHA5A003272, HHA5B003376 thru HHA5B003379, HHA5C004130, HHA5C004135, HHA5C004151, HHA5C004472, HHA5C004483, HHA5C004496, HHA5C004509, HHA5C004517, HHAZA003070, HHAZA003072 thru HHAZA003074, HHAZC004203, HHAZC004220, HHAZC004473, SHHA5B003478, SHHA5C004069, HHA5A003100 thru HHA5A003103, HHA5A003105 thru HHA5A003109, HHA5C004469, HHA59001440 thru HHA59001449, HHA59001578, HHA59001582, HHA59001584, HHA5A002980 thru HHA5A002989, HHA5A003120 thru HHA5A003129, HHA5B003389 thru HHA5B003394, HHA5B003396 thru HHA5B003399, HHA5B003453 thru HHA5B003460, HHA5C004109, HHA5C004118, HHA5C004120, HHA5C004128, HHA5C004136, HHA5C004140, HHA5C004148, HHA5C004487, HHA5C004489 thru HHA5C004492, HHA5C004494, HHA5C004497 thru HHA5C004499, HHA5C004502, HHA5C004532 thru HHA5C004535, HHA5C004537, HHA5C004541 thru HHA5C004545, HHA5B003525, HHA5C004085, HHA5C004093, HHA5C004099, HHA59001400 thru HHA59001408, HHA59001491, HHA5C004101, HHA5C004206, HHA5C004211, HHA5C004218, HHA5C004253, HHA5C004256, HHA5A003060 thru HHA5A003069, HHA5A003130 thru HHA5A003139, HHA5A003161, HHA5A003177, HHA5A003202 thru HHA5A003211, HHA5A003236, HHA5A003265 thru HHA5A003270, HHA5A003273 thru HHA5A003279, HHA5C004129, HHA5C004133, HHA5C004139, HHA5C004141, HHA5C004145 thru HHA5C004146, HHA5C004549, HHA5B003356 thru HHA5B003357, HHA5B003359 thru HHA5B003361, HHA5B003431, HHA5B003435, HHA5C004131, HHA5A002990 thru HHA5A002996, HHA5A002998 thru HHA5A002999, HHA5A003001 thru HHA5A003009, HHA5A003041 thru HHA5A003043, HHA5A003045 thru HHA5A003049, HHA5A003076, HHA5A003192 thru HHA5A003201, HHA5C004117, HHA5C004149, HHA5C004548, HHA59001487, HHA5A003111 thru HHA5A0031112, HHA5B003303, HHA5C004550, HHA59001360 thru HHA59001362, HHA59001364, HHA59001366 thru HHA59001369, HHA59001431, HHA59001436, HHA5B003337 thru HHA5B003339, HHA5B003344, HHA5B003867, HHA5C004090, HHA5B003286, HHA5B003380 thru HHA5B003382, HHA5B003385, HHA5B003387, HHA59001392, HHA59001394 thru HHA59001399, HHA59001433, HHA59001437 thru HHA59001438, HHA59001560, HHA59001606, HHA59001617, HHA5A003015, HHA5C004062, HHA5C004501, HHA57000136, HHA57000142, HHA58000550, HHA58000559 thru HHA58000567, HHA58000642 thru HHA58000649, HHA58000856 thru HHA58000857, HHA58000869 thru HHA58000885, HHA58000887 thru HHA58000889, HHA58000945 thru HHA58000954, HHA5A003010 thru HHA5A003013, HHA5A003016 thru HHA5A003019, HHA5C004476, HHA57000400, HHA57000403, HHA57000405 thru HHA57000406, HHA57000408 thru HHA5700409, HHA5700411, HHA5700413 thru HHA57000415, HHA57000440, HHA57000443, HHA57000445, HHA57000485, HHA57000487, HHA57000489 thru HHA57000490, HHA57000493, HHA57000495 thru, HHA57000499, HHA58000594 thru HHA58000595, HHA58000598, HHA58000610, HHA58000612 thru HHA58000615, HHA58000617 thru HHA58000620 thru HHA58000622, HHA58000625, HHA58000628 thru HHA5800030, HHA58000922 thru HHA58000936, HHA58000940, HHA58000942 thru HHA58000944, HHA5C004073, HHA5C004121, HHA5C004156, HHA5C004478, HHA5C004213, HHA5C004219, HHA5C004224, HHA5C004226, HHA5C004229, HHA5C004242, HHA5C004079, HHA5C004112, HHA5C004115, HHA5C004119, HHA5C004122, HHA5C004124 thru HHA5C004125, HHA5C004146, HHA5C004150, HHA5C004155, HHA5C004510, HHA5C004519, HHA5B003323 thru HHA5B003325, HHA5B003327 thru HHA5B003332, HHA5B003334, HHA5B003432 thru HHA5B003434, HHA5B003436, HHA5B003438 thru HHA5B003439, HHA5B003395, HHA5B003461 thru HHA5B003464, HHA5B003466, HHA5B003290 thru HHA5B003291, HHA5B003437, HHA5B003440, HHA5B003292 thru HHA5B003294, HHA5B003296 thru HHA5B003300, HHA5B003363, HHA5B003384, HHA5B003388, HHA5B003467, HHA57000361, HHA59001354, HHA59001380 thru HHA59001382, HHA59001390 thru HHA59001391, HHA5B003366 thru HHA5B003375, HHA5B003326, HHA5C004173, HHA5C004202, HHA5C004228, HHA5C004239, HHA58001016, HHA58001018, HHA58001021 and HHA58001024, HHA58001026, HHA58001028, HHA58001035, HHA58001041, HHA5B003281 thru HHA5B003285, HHA5B003287 thru HHA5B003288, HHA5B003345 thru HHA5B003346, HHA5B003348 thru HHA5B003352, HHA5B003354 thru HHA5B003355, HHA5C004466, HHA57000185 thru HHA57000194, HHA57000225 thru HHA57000226, HHA57000228 thru HHA57000230, HHA57000232 thru HHA57000233, HHA57000366 thru HHA57000368, HHA57000390 thru HHA57000397, HHA57000401 and HHA57000402, HHA57000404, HHA57000407, HHA57000410, HHA57000412, HHA57000416 thru HHA57000437, HHA57000439, HHA57000441 thru HHA57000442, HHA57000444, HHA57000446 thru HHA57000447, HHA57000449 and HHA57000450, HHA57000454 thru HHA57000471, HHA57000473 and HHA57000481, HHA57000484, HHA57000486, HHA57000491 thru HHA57000492, HHA57000494, HHA57000500 thru HHA57000502, HHA57000504 thru HHA57000506, HHA57000510, HHA57000513, HHA57000516 thru HHA57000517, HHA58000582, HHA59001345, HHA59001383 thru HHA59001384, HHA59001434 thru HHA59001435, HHA59001744, HHA5C004153, HHA5C004166, HHA5C004180, HHA5c004184, HHA5C004234, HHA5C004236, HHA61004579, HHA5A003020 thru HHA5A003039, HHA5A003082 thru HHA5A003083, HHA5A003086 thru HHA5A003089, HHA5A003140 thru HHA5A003160, HHA5A003162 thru HHA5A003170, HHA5A003182 thru HHA5A003191, HHA5A003222 thru HHA5A003235, HHA5A003237 thru HHA5A003262, HHA5B003335 thru HHA5B003336, HHA5B003340 thru HHA5B003343, HHA5A003050 thru HHA5A003059, HHA5A003090 thru HHA5A003099, HHA5A003171 thru HHA5A003181, HHA5C004158, HHA5C004162 thru HHA5C004163, HHA5C004167 thru HHA5C004169, HHA5C004172, HHA5C004175, HHA5C004179, HHA5C004181, HHA5C004183, HHA5C004185 , HHA5C004192, HHA5C004204, HHA5C004207, HHA5C004209, HHA5C004215, HHA5C004223, HHA5C004225, HHA5C004231, HHA5C004237, HHA5C004243, HHA5C004245, HHA5C004251, HHA5C004254, HHA5C004453 thru HHA5C004457, HHA5C004460, HHA5C004468, HHA5C004471, HHA5C004474 thru HHA5C004475, HHA5C004479 thru HHA5C004481, HHA5C004484, HHA5C004488, HHA5C004493, HHA5C004495, HHA5C004505, HHA5C004512 thru HHA5C004515, HHA5C004518, HHA5C004520, HHA5C004526 thru HHA5C004527, HHA5C004529, HHA5C004539 thru HHA5C004540, HHA5C004547, HHA5C004552, HHAZC004467, HHAZC004482, HHA5800573, HHA58000603, HHA58000959, HHA58000962, HHA58000982, HHA58001049 thru HHA58001050, HHA58001053 thru HHA58001054, HHA59001349 thru HHA59001353, HHA59001355 thru HHA59001359, HHA59001483, HHA59001488 thru HHA59001490, HHA59001539, HHA59001541 thru HHA59001548, HHA59001551 thru HHA59001555, HHA59001557 thru HHA59001559, HHA59001561 thru HHA59001577, HHA599001579, HHA59001581, HHA59001583, HHA59001585 thru HHA59001590, HHA59001592 thru HHA59001605, HHA59001607 thru HHA59001608, HHA59001610 thru HHA59001614, HHA59001616, HHA59001618 thru HHA59001625, HHA59001627 thru HHA59001631, HHA59001633 thru HHA59001636, HHA5B003280, HHA5B003290, HHA5B03301, HHA5B003304 thru HHA5B003307, HHA5B003309 thru HHA5B003312, HHA5C004078, HHA5C004132, HHA5C004138, HHA5C004142, HHA5C004147, HHA5C004154, HHA5C004157, HHA5C004161, HHA5C004164 thru HHA5C004165, HHA5C004176, HHA5C004182, HHA5C004187 thru HHA5C004191, HHA5C004193, HHA5C004201, HHA5C004214, HHA5C004217, HHA5C004221, HHA5C004227, HHA5C004232, HHA5C004241, HHA5C004244, HHA58000551 thru HHA58000553, HHA58000555 thru HHA58000558, HHA58000568 thru HHA58000572, HHA58000574 thru HHA58000575, HHA58000577, HHA58000579 thru HHA58000581HHA58000602, HHA58000621, HHA58000640, HHA58000963 thru HHA58000072, HHA58001029 thru HHA58001034, HHA58001036, HHA58001038 thru HHA58001040, HHA5A003271, HHA5B003465, HHAZ800590, HHAZ800601, HHAZ800623, HHA5C004459, HHA5C004461 thru HHA5C004463, HHA5C004177, HHA5C004195, HHA5C004248, HHA5C004504, HHA5C004506, HHA5C004508, HHA5C004511, HHA5C004522 thru HHA5C004525, HHA5C004528, HHA5C004530 thru HHA5C004531, HHA5C004536, HHA5C004538, HHA5C004057, HHA5C004072, HHA5C004083, HHA5C004088, HHA5C004114, HHA5C004159, HHA5C004170 thru HHA5C004171, HHA5C004199, HHA5C004208, HHA5C004212, HHA5C004230, HHA5C004235, HHA5C004246, HHA5C004250 thru HHA5C004251, HHA5B003362, HHA5B003364, HHA5A03212 thru HHA5A003221, HHA5C004210, HHA5C004216, HHA5C00422, HHA5C004255 and HHA5C004486
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US and Canada
  • 제품 설명
    TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America