HillRom 100 Bed 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
    55156
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2268-2010
  • 사례 시작날짜
    2009-04-13
  • 사례 출판 날짜
    2010-08-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-06-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    hospital bed - Product Code FNL
  • 원인
    Pinch hazard. potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed.
  • 조치
    Hill-Rom sent a customer notification letter dated 4/9/2009. A second notice was sent to all customers on 7/9/2009. The letter included instructions and a Customer Response Form, along with the required parts. Customers were instructed to do the correction on their affected beds and return the completed customer response form within 45 days.

Device

  • 모델명 / 제조번호(시리얼번호)
    K029AP6787, K029AP6788, K029AP6790, J317AP5267, J206AP2503, J206AP2506, J206AP2511, J206AP2513, J213AP2581, J220AP2773, J220AP2775, J220AP2777, J220AP2778, J224AP2904, J224AP2906, J224AP2907, J224AP2908, J220AP2770, J224AP2909, J224AP2916, J227AP3052, J227AP3053, K027AP6733, K027AP6735, K027AP6736, K027AP6738, J220AP2772, J220AP2774, J224AP2905, J274AP4108, J274AP4113, J274AP4114, J274AP4134, J274AP4135, J274AP4136, J274AP4102, J350AP5889, J350AP5890, J350AP5891, J350AP5892, J350AP5893, J350AP5894, J350AP5895, J350AP5896, J350AP5897, J350AP5899, J350AP5900, J350AP5901, J350AP5902, J350AP5903, J350AP5904, J350AP5905, J350AP5906, J350AP5907, J350AP5908, J350AP5909, J350AP5998, J352AP5988, J352AP5989, J352AP5990, J352AP5991, J352AP5992, J352AP5993, J352AP5994, J352AP5995, J352AP5996, J352AP5997, J352AP5998, J352AP5999, J352AP6000, J352AP6001, J352AP6002, J352AP6003, J352AP6004, J352AP6005, J352AP6006, J352AP6007, J352AP6008, J352AP6009, J352AP6010, J352AP6011, J352AP6012, K020AP6555, K020AP6556, K020AP6557, K020AP6558, K020AP6559, K020AP6560, J354AP6044, J354AP6045, J354AP6046, J354AP6047, J354AP6048, J354AP6049, J354AP6050, J354AP6051, J354AP6052, J354AP6053, J354AP6054, J354AP6056, J354AP6057, J354AP6058, J354AP6059, J354AP6042, J354AP6043, J274AP4103, J274AP4105, J274AP4106, J274AP4107, J274AP4109, J274AP4110, J274AP4111, J274AP4115, J274AP4117, J274AP4118, J274AP4120, J274AP4125, J274AP4127, J274AP4129, J274AP4132, J274AP4137, J274AP4138, J282AP4359, J282AP4365, J282AP4366, J324AP5383, J324AP5384, J324AP5385, J324AP5386, K027AP6720, K027AP6723, K027AP6726, K027AP6727, K027AP6728, K027AP6729, K027AP6730, K027AP6731, K027AP6732, K027AP6734, K027AP6737, K027AP6739, K027AP6740, K027AP6741, K027AP6742, K028AP6773, K028AP6774, K038AP6999, K038AP7000, K038AP7001, K038AP7002, J274AP4099, J274AP4100, J274AP4112, J274AP4116, J274AP4119, J274AP4122, J274AP4126, J274AP4131, J206AP2509, J213AP2580, J220AP2764, J220AP2767, J227AP3035, J227AP3036, J227AP3037, J227AP3039, J227AP3040, J227AP3041, J227AP3042, J227AP3043, J227AP3044, J227AP3045, J227AP3046, J227AP3047, J227AP3048, J227AP3049, J227AP3051, J206AP2508, J206AP2512, J213AP2578, J213AP2579, J206AP2505, J220AP2761, J220AP2762, J220AP2763, J220AP2765, J220AP2766, J220AP2768, J220AP2769, J227AP3038, J274AP4097, J274AP4098, J274AP4104, J274AP4128, J274AP4130, J274AP4133, K006AP6220, K006AP6221, J309AP4986, J309AP4987, J309AP4988, J309AP4989, J309AP4990, J309AP4991, J143AP0940, J143AP0941, J143AP0937, J143AP0944, J143AP0943, J220AP2788, J220AP2789, J274AP4121, J206AP2504, J206AP2507, J206AP2510, J206AP2514, J240AP3514, J317AP5268, J317AP5269, J143AP0945, J143AP0946, J220AP2771, J220AP2776, J220AP2779, J220AP2780, J220AP2781, J220AP2790, J220AP2791, J220AP2792, J227AP3054, J227AP3055, J227AP3056, J239AP3425, J239AP3426, J239AP3428, J239AP3429, J239AP3430, J239AP3431, J239AP3432, J143AP0939, J354AP6055 and J303AP4873.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Afghanistan, Algeria, American Samoa, Argentina, Australia, Bermuda, Brazil, Canada, Chili, China, Colombia, Costa Rica, Cuba, Ecuador, Egypt, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Kyrgyzstan, Lebanon, Libya, Malaysia, Mexico, Oman, Panama, Paraguay, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Syria, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.
  • 제품 설명
    Hill-Rom 1000 bed model P1160.
  • Manufacturer

Manufacturer

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