Events

Device Recall VersaCare beds 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hill-Rom, 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
    57944
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1564-2011
  • 사례 시작날짜
    2011-02-21
  • 사례 출판 날짜
    2011-03-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97796
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 원인
    Hill-rom has become aware of a potential issue with some totalcare¿ and versacare¿ beds equipped with the integrated p500 microclimate management (mcm) therapy surface, and with the versacare¿ p500 mcm surface upgrade. because of an unauthorized vendor part modification, it is possible that the mcm blower may not perform as originally designed. given this modification, the mcm blower may experi.
  • 조치
    Hill-Rom sent an "IMPORTANT MEDICAL DEVICE CORRECTION" notice dated February 21, 2011, to Facility Risk Manager/Facility Administrators. The letter states that because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experience the following: delayed start, slow running, or failure to operate.This issue does not pose a hazard to patients as long as normal patient monitoring is in effect in relation to managing skin temperature and moisture. Customers were instructed to continue to use the product as they normally would. The mattress system would provide an alarm in the event the MCM blower does not operate properly. A Hill-Rom representative would be contacting their facility to make arrangements for correcting the affected MCM blowers. If customers had any questions concerning this request or the procedure as outlined, they were instructed to contact Hill-Rom Technical Support at 800-445-3720. For questions regarding this recall call 812-934-7777.

Device

Device Recall VersaCare beds
  • 모델명 / 제조번호(시리얼번호)
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L342AD9053, L342AD9060, L342AD9071, L342AD9073, L342AD9087, L342AD9091, L343AD9175, L343AD9178, L343AD9181, L343AD9184, L343AD9191, L343AD9194, L343AD9197, L343AD9200, L343AD9203, L343AD9208, L343AD9211, L343AD9214, L343AD9217, L343AD9221, L343AD9222, L343AD9227, L343AD9233, L343AD9253, L344AD9340, L344AD9346, L344AD9395, L345AD9536, L345AD9539, L345AD9542, L345AD9545, L345AD9548, L345AD9551, L345AD9554, L345AD9557, L345AD9560, L345AD9566, L345AD9570, L345AD9573, L345AD9578, L345AD9579, L345AD9583, L345AD9595, L345AD9598, L345AD9601, L345AD9608, L345AD9614, L345AD9616, L345AD9618, L347AD9641, L347AD9646, L347AD9654, L347AD9656, L347AD9658, L347AD9660, L347AD9662, L347AD9668, L347AD9672, L347AD9676, L347AD9680, L347AD9682, L347AD9686, L347AD9688, L347AD9691, L347AD9695, L347AD9699, L347AD9701, L347AD9703, L347AD9705, L347AD9707, L347AD9709, L348AD9712, L348AD9713, L348AD9719, L348AD9751, L348AD9753, L348AD9755, L348AD9757, L348AD9759, L348AD9761, L348AD9763, L348AD9765, L348AD9767, L348AD9769, L349AD9862, L349AD9864, L349AD9867, L349AD9868, L349AD9869, L349AD9871, L349AD9873, L349AD9875, L350AD9877, L350AD9879, L350AD9881, L350AD9883, L350AD9885, L350AD9887, L350AD9889, L350AD9891, L350AD9893, L350AD9895, L350AD9897, L350AD9899, L350AD9901, L350AD9903, L350AD9905, L350AD9907, L350AD9909, L350AD9911, L350AD9913, L350AD9915, L350AD9917, L350AD9919, L350AD9922, L350AD9924, L350AD9926, L350AD9928, L350AD9930, L350AD9931, L350AD9932, L350AD9934, L350AD9935, L350AD9937, L350AD9938, L350AD9939, L350AD9941, L350AD9942, L350AD9944, L350AD9946, L350AD9948, L350AD9950, L350AD9952, L350AD9954, L350AD9955, L350AD9956, L350AD9958, L350AD9959, L350AD9960, L351AD0000, L351AD0003, L351AD0007, L351AD9962, L351AD9963, L351AD9964, L351AD9966, L351AD9967, L351AD9968, L351AD9970, L351AD9971, L351AD9972, L351AD9974, L351AD9975, L351AD9976, L351AD9978, L351AD9979, L351AD9980, L351AD9982, L351AD9983, L351AD9984, L351AD9986, L351AD9987, L351AD9988, L351AD9990, L351AD9991, L351AD9993, L351AD9996, L355AD0209, L355AD0211, L355AD0213, L355AD0215, L355AD0217, L355AD0219, L356AD0222, L356AD0224, L356AD0226, L356AD0228, L356AD0249, L356AD0251, L356AD0252, L356AD0254, L357AD0333, L357AD0342, L357AD0344, L357AD0347, L357AD0351, L357AD0352, L357AD0355, L357AD0356, L357AD0358, L357AD0367, L357AD0369, L357AD0370, M003AD0384, M003AD0387, M003AD0390, M003AD0393, M003AD0396, M003AD0399, M003AD0405, M003AD0408, M003AD0411, M003AD0412, M003AD0415, M003AD0433, M003AD0435, M004AD0468, M004AD0469, M004AD0481, M005AD0543, M005AD0545, M005AD0547, M005AD0550, M005AD0554, M005AD0558, M005AD0560, M005AD0562, M005AD0564, M005AD0565, M005AD0566, M005AD0568, M005AD0570, M005AD0572, M005AD0574, M006AD0615, M006AD0621, M006AD0622, M006AD0623, M006AD0625, M006AD0627, M006AD0631, M006AD0632, M006AD0634, M006AD0637, M006AD0638, M006AD0656, M006AD0660, M006AD0668, M006AD0670, M006AD0672, M006AD0673, M006AD0676, M006AD0679, M006AD0682, M006AD0685, M006AD0694, M006AD0698, M006AD0702, M006AD0709, M006AD0713, M007AD0718, M007AD0719, M007AD0723, M007AD0740, M007AD0741, M007AD0749, M007AD0750, M007AD0753, M007AD0762, M007AD0763, M007AD0766, M007AD0767, M007AD0769, M007AD0770, M007AD0771, M007AD0778, M007AD0780, M010AD0790, M010AD0793, M010AD0796, M010AD0800, M010AD0801, M010AD0802, M010AD0805, M010AD0808, M010AD0821, M010AD0824, M010AD0828, M011AD0884, M011AD0904, M011AD0907, M011AD0908, M011AD0911, M011AD0913, M011AD0915, M011AD0916, M011AD0918, M011AD0922, M011AD0924, M011AD0926, M011AD0928, M011AD0930, M011AD0932, M011AD0935, M011AD0937, M011AD0940, M011AD0944, M011AD0946, M011AD0948, M011AD0950, M011AD0951, M012AD0959, M012AD0960, M012AD0963, M012AD0964, M012AD0967, M012AD0969, M012AD0973, M012AD0975, M012AD0976, M012AD0977, M012AD0979, M012AD0980, M012AD0982, M012AD0983, M012AD0985, M012AD0990, M012AD0993, M012AD0998, M012AD0999, M012AD1000, M012AD1001, M012AD1002, M012AD1003, M012AD1004, M012AD1005, M012AD1006, M012AD1007, M012AD1008, M012AD1009, M012AD1010, M012AD1011, M012AD1012, M012AD1013, M012AD1014, M012AD1015, M012AD1016, M012AD1017, M012AD1019, M012AD1021, M013AD1024, M013AD1025, M013AD1027, M013AD1029, M013AD1030, M013AD1033, M013AD1035, M013AD1037, M013AD1039, M013AD1043, M013AD1044, M013AD1045, M013AD1047, M013AD1048, M013AD1050, M013AD1051, M013AD1052, M013AD1054, M013AD1055, M013AD1060, M013AD1062, M013AD1064, M013AD1070, M013AD1072, M013AD1073, M013AD1074, M013AD1076, M013AD1077, M013AD1078, M013AD1080, M013AD1081, M013AD1083, M013AD1084, M013AD1086, M013AD1087, M013AD1088, M013AD1109, M017AD1298, M017AD1299, M017AD1300, M017AD1301, M017AD1302, M017AD1303, M018AD1310, M018AD1311, M018AD1312, M018AD1313, M018AD1317, M018AD1321, M018AD1325, M018AD1331, M018AD1334, M018AD1336, M018AD1343, M018AD1349, M018AD1369, M019AD1397, M019AD1470, M019AD1471, M020AD1482, M020AD1484, M020AD1488, M020AD1489, M020AD1491, M020AD1493, M020AD1495, M020AD1498, M020AD1501, M020AD1502, M020AD1504, M020AD1508, M020AD1509, M020AD1510, M020AD1512, M020AD1513, M020AD1515, M020AD1516, M020AD1517, M020AD1521, M020AD1522, M020AD1523, M020AD1525, M020AD1528, M020AD1530, M020AD1532, M020AD1534, M027AD1921, M028AD3004, M028AD3005, M029AD3084, M029AD3092, M029AD3096, M029AD3098, M029AD3100, M029AD3102, M031AD3156, M031AD3159, M031AD3162, M031AD3166, M031AD3172, M031AD3175, M034AD3206, M034AD3238, M034AD3240, M034AD3244, M034AD3246, M035AD3291 and M035AD3305.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, CA, CO, CT, DC, DE, FL, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WI, and the countries of ARUBA, AUSTRIA, CANADA, FRANCE, GERMANY, LEBANON, PORTUGAL and SAUDI ARABIA
  • 제품 설명
    VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. || The VersaCare¿ Bed System is intended to provide a patient support suited to be used in healthcare environments. The VersaCare¿ Bed may be used in such settings as acute care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED).
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • 제조사 주소
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA