Events

Device Recall Philips Healthcare SureSigns VS2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    64070
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0824-2013
  • 사례 시작날짜
    2013-01-14
  • 사례 출판 날짜
    2013-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115317
  • 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, measurement, blood-pressure, non-invasive - Product Code DXN
  • 원인
    Vs2+ screen may lock up and stop monitoring during patient use.
  • 조치
    Philips issued an Urgent Medical Device Correction letter on January 14, 2013. The field action will take place in two phases: Phase 1 Philips sent customer an Urgent Medical Device Correction Notification/Field Safety Notice. This notification explains the issues and gives the customers instructions on actions to take while they await the hardware correction. Phase 2 Once the hardware correction Philips will contact customers and perform the correction free of charge. Until the correction is available. Affected products may continue to be used while waiting for the correction from Philips if the unit is not used in NBP interval mode. A Philips Healthcare representative will contact you to arrange for the correction of all affected devices. If you need any further information or support concerning this issue, please contact the Philips Customer Care Center at 1-800-722-9377. On 3/14/13, firm stated Initially the fix would be a hardware upgrade but have since changed that to a software update. Customers within the US will be sent a new Field Safety Notice as well as a USB software update package and will be required to notify us upon the upgrade of their affected units. They will be performing the updates themselves

Device

Device Recall Philips Healthcare SureSigns VS2
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: CN14800428, CN14800429, CN14800430, CN14800431, CN14800432, CN14800433, CN14800434, CN14800435, CN14800436, CN14800437, CN14800438, CN14800439, CN14800440, CN14800756, CN14800763, CN14800764, CN14800765, CN14800772, CN14800773, CN14800822, CN14800823, CN14800824, CN14800979, CN14801332, CN21201423, CN21201625, CN21202029, CN21202030, CN21202031, CN21202032, CN21202033, CN21202034, CN21202234, CN21202239, CN21202240, CN21202241, CN21202242, CN21202243, CN21202317, CN21202320, CN21202347, CN21202348, CN21202349, CN21202350, CN21202351, CN21202376, CN21202435, CN21202606, CN21202607, CN21202862, CN21202863, CN21202883, CN21203006, CN21203007, CN21203008, CN21203009, CN21203010, CN21203073, CN21203180, CN21203304, CN21203307, CN21203308, CN21203309, CN21203310, CN21203311, CN21203312, CN21203707, CN21203781, CN21203794, CN21203795, CN21203796, CN21203797, CN21203949, CN21203950, CN21203951, CN21203952, CN21203953, CN21204204, CN21204205, CN21204206, CN21204207, 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CN21203538, CN21203539, CN21203540, CN21203541, CN21203542, CN21203543, CN21203544, CN21203545, CN21203546, CN21203547, CN21203548, CN21203549, CN21203550, CN21203551, CN21203552, CN21203553, CN21203554, CN21203555, CN21203556, CN21203557, CN21203558, CN21203559, CN21203560, CN21203561, CN21203562, CN21203563, CN21203564, CN21203565, CN21203566, CN21203567, CN21203568, CN21203569, CN21203570, CN21203571, CN21203572, CN21203573, CN21203574, CN21203575, CN21203576, CN21203577, CN21203578, CN21203579, CN21203580, CN21203581, CN21203582, CN21203583, CN21203584, CN21203585, CN21203586, CN21203587, CN21203588, CN21203589, CN21203590, CN21203591, CN21203592, CN21203593, CN21203594, CN21203595, CN21203596, CN21203597, CN21203598, CN21203599, CN21203600, CN21203601, CN21203602, CN21203603, CN21203604, CN21203605, CN21203606, CN21203607, CN21203608, CN21203609, CN21203610, CN21203611, CN21203612, CN21203613, CN21203614, CN21203615, CN21203616, CN21203619, CN21203620, CN21203621, CN21203622, CN21203623, CN21203624, CN21203625, CN21203640, CN21203641, CN21203642, CN21203643, CN21203644, CN21203645, CN21203646, CN21203647, CN21203648, CN21203649, CN21203650, CN21203651, CN21203652, CN21203653, CN21203654, CN21203655, CN21203656, CN21203657, CN21203658, CN21203659, CN21203660, CN21203661, CN21203662, CN21203663, CN21203664, CN21203665, CN21203666, CN21203667, CN21203668, CN21203669, CN21203670, CN21203671, CN21203672, CN21203673, CN21203674, CN21203675, CN21203676, CN21203677, CN21203678, CN21203679, CN21203680, CN21203681, CN21203682, CN21203683, CN21203684, CN21203685, CN21203686, CN21203687, CN21203688, CN21203689, CN21203690, CN21203691, CN21203692, CN21203693, CN21203694, CN21203695, CN21203696, CN21203697, CN21203698, CN21203699, CN21203700, CN21203701, CN21203704, CN21203705, CN21203715, CN21203716, CN21203717, CN21203718, CN21203719, CN21203720, CN21203721, CN21203722, CN21203723, CN21203724, CN21203732, CN21203733, CN21203734, CN21203735, CN21203742, CN21203743, CN21203780, CN21203828, CN21203839, CN21203840, CN21203841, CN21203842, CN21203843, CN21203844, CN21203845, CN21203846, CN21203847, CN21203848, CN21203849, CN21203850, CN21203851, CN21203852, CN21203853, CN21203854, CN21203855, CN21203856, CN21203857, CN21203858, CN21203859, CN21203860, CN21203861, CN21203862, CN21203863, CN21203864, CN21203865, CN21203866, CN21203867, CN21203868, CN21203869, CN21203886, CN21203926, CN21203927, CN21203928, CN21203938, CN21203939, CN21203940, CN21203941, CN21203942, CN21203943, CN21203944, CN21203945, CN21203967, CN21203968, CN21203969, CN21204005, CN21204013, CN21204029, CN21204030, CN21204031, CN21204032, CN21204033, CN21204034, CN21204035, CN21204036, CN21204037, CN21204038, CN21204039, CN21204040, CN21204041, CN21204049, CN21204050, CN21204051, CN21204052, CN21204053, CN21204054, CN21204055, CN21204056, CN21204057, CN21204058, CN21204059, CN21204060, CN21204061,  CN21204062, CN21204063, CN21204064, CN21204065, CN21204066, CN21204067, CN21204068, CN21204069, CN21204070, CN21204071, CN21204072, CN21204073, CN21204074, CN21204075, CN21204076, CN21204077, CN21204078, CN21204079, CN21204080, CN21204081, CN21204082, CN21204083, CN21204084, CN21204085, CN21204086, CN21204087, CN21204088, CN21204089, CN21204090, CN21204091, CN21204092, CN21204093, CN21204094, CN21204095, CN21204096, CN21204097, CN21204098, CN21204099, CN21204100, CN21204101, CN21204119, CN21204131, CN21204134, CN21204144, CN21204145, CN21204201, CN21204202, CN21204224, CN21204226, CN21204283, CN21204284, CN21204285, CN21204286, CN21204287, CN21204292, CN21204309, CN21204310, CN21204311, CN21204312, CN21204317, CN21204322, SP13701043, USPP101007, CN21201390, CN21201500, CN21201501, CN21201502, CN21201503, CN21201505, CN21201506, CN21201507, CN21201508, CN21201509, CN21201510, CN21201511, CN21201512, CN21201513, CN21201514, CN21201515, CN21201516, CN21201517, CN21201518, CN21201519, CN21201520, CN21201521, CN21201522, CN21201523, CN21201524, CN21201525, CN21201526, 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CN21201839, CN21201840, CN21201841, CN21201842, CN21201843, CN21201872, CN21201873, CN21201874, CN21201875, CN21201876, CN21201877, CN21201878, CN21201879, CN21201880, CN21201881, CN21201882, CN21201883, CN21201884, CN21201885, CN21201902, CN21201903, CN21201904, CN21201905, CN21201906, CN21201907, CN21201908, CN21201909, CN21201910, CN21201911, CN21201912, CN21201913, CN21201914, CN21201915, CN21201916, CN21201986, CN21201987, CN21201992, CN21202039, CN21202093, CN21202162, CN21202163, CN21202203, CN21202204, CN21202205, CN21202236, CN21202237, CN21202323, CN21202339, CN21202340, CN21202341, CN21202342, CN21202343, CN21202344, CN21202346, CN21202374, CN21202375, CN21202395, CN21202396, CN21202397, CN21202398, CN21202399, CN21202400, CN21202401, CN21202402, CN21202403, CN21202404, CN21202405, CN21202406, CN21202407, CN21202408, CN21202409, CN21202410, CN21202411, CN21202412, CN21202413, CN21202414, CN21202481, CN21202482, CN21202483, CN21202484, CN21202485, CN21202486, CN21202487, CN21202488, CN21202489, CN21202490, CN21202491, CN21202492, CN21202493, CN21202494, CN21202495, CN21202496, CN21202497, CN21202498, CN21202499, CN21202500, CN21202501, CN21202502, CN21202503, CN21202504, CN21202505, CN21202506, CN21202507, CN21202508, CN21202509, CN21202510, CN21202511, CN21202512, CN21202513, CN21202514, CN21202670, CN21202671, CN21202672, CN21202673, CN21202674, CN21202675, CN21202681, CN21202682, CN21202684, CN21202685, CN21202686, CN21202687, CN21202841, CN21203031, CN21203046, CN21203047, CN21203048, CN21203049, CN21203050, CN21203051, CN21203052, CN21203053, CN21203074, CN21203075, CN21203076, CN21203077, CN21203078, CN21203079, CN21203080, CN21203081, CN21203082, CN21203083, CN21203084, CN21203085, CN21203086, CN21203087, CN21203088, CN21203089, CN21203090, CN21203091, CN21203092, CN21203093, CN21203094, CN21203095, CN21203154, CN21203155, CN21203156, CN21203157, CN21203189, CN21203190, CN21203191, CN21203192, CN21203193, CN21203194, CN21203214, CN21203215, CN21203216, CN21203217, CN21203218, CN21203219, CN21203220, CN21203221, CN21203232, CN21203233, CN21203234, CN21203235, CN21203236, CN21203237, CN21203238, CN21203239, CN21203240, CN21203241, CN21203242, CN21203243, CN21203244, CN21203245, CN21203246, CN21203247, CN21203248, CN21203249, CN21203250, CN21203251, CN21203252, CN21203290, CN21203291, CN21203292, CN21203293, CN21203294, CN21203295, CN21203296, CN21203297, CN21203323, CN21203324, CN21203337, CN21203338, CN21203339, CN21203363, CN21203383, CN21203384, CN21203385, CN21203386, CN21203387, CN21203393, CN21203394, CN21203395, CN21203396, CN21203397, CN21203404, CN21203405, CN21203406, CN21203407, CN21203408, CN21203409, CN21203410, CN21203411, CN21203412, CN21203413, CN21203414, CN21203417, CN21203462, CN21203463, CN21203464, CN21203465, CN21203466, CN21203467, CN21203636, CN21203709, CN21203710, CN21203711, CN21203712, CN21203741, CN21203750, CN21203751, CN21203752, CN21203753, CN21203829, CN21203830, CN21203831, CN21203832, CN21203833, CN21203834, CN21203835, CN21203836, CN21203837, CN21203838, CN21203871, CN21203872, CN21203873, CN21203874, CN21203875, CN21203876, CN21203877, CN21203878, CN21203879, CN21203880, CN21203881, CN21203882, CN21203883, CN21203884, CN21203885, CN21203900, CN21203901, CN21203902, CN21203903, CN21203904, CN21203905, CN21203906, CN21203907, CN21203908, CN21203909, CN21203910, CN21203911, CN21203912, CN21203913, CN21203914, CN21203915, CN21203916, CN21203917, CN21203918, CN21203919, CN21203920, CN21203921, CN21203922, CN21203923, CN21203954, CN21203955, CN21203956, CN21203957, CN21203958, CN21203962, CN21203963, CN21203964, CN21203971, CN21203972, CN21203973, CN21203974, CN21203975, CN21203976, CN21203977, CN21203978, CN21203979, CN21203980, CN21203981, CN21203982, CN21203983, CN21203984, CN21203995, CN21203996, CN21203997, CN21203998, CN21204006, CN21204012, CN21204014, CN21204015, CN21204123, CN21204124, CN21204212, CN21204213, CN21204216, CN21204217, CN21204275, CN21204276, CN21204277, CN21204278, CN21204279, CN21204280, CN21204281, CN21204282, CN21204316, CN21204326, CN21204327, CN21204328, CN21204373, CN21204374, USPP3NCK10
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: AUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE GERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA KUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND NORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES UNITED KINGDOM
  • 제품 설명
    Philips Healthcare SureSigns VS2+ || Model 863278 SureSigns VS2+ NBP and SpO2 || Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature || Product Usage: || The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA