Events

Medcare Products Max500 Stand, Total Support 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ergosafe Products LLC DBA Prism Medical Services USA 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
    66056
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0371-2014
  • 사례 시작날짜
    2013-10-30
  • 사례 출판 날짜
    2013-11-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121498
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • 원인
    The lift might fail with the labeled 500-lb. load rating.
  • 조치
    The firm, Medcare Products, sent an "URGENT FIELD CORRECTIVE ACTIONS" letter dated October 21, 2013 via certified mail on October 30, 2013 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to peel off the boom stickers and serial number label and replace with the new ones supplied; review the revised Manual and dispose of the original; and complete the action report form once the products have been relabeled. Please refer to your Operations Manual or visit our website at www.medcarelifts.com to view the manual online. If we can answer any questions that you may have regarding the testing standards or the relabeling of the products, please do not hesitate to contact us at 1-800-695-4479.

Device

Medcare Products Max500 Stand, Total Support
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0106SWH0008, 0106SWH0009, 0106SWH0010, 0107SWH0031, 0107SWH0032, 0107SWH0033, 0107SWH0034, 0108SWH0044, 0108SWH0045, 0109SWH0065, 0109SWH0066, 0109SWH0067, 0109SWH0068, 0109SWH0069, 0109SWH0070,  0109SWH0071, 0111SWH0148, 0111SWH0149, 0111SWH0150,  0111SWH0151, 0112SWH0199, 0112SWH0200, 0112SWH0201, 0112SWH0202, 0112SWH0203, 0112SWH0204, 0206SWH0011, 0206SWH0012, 0209SWH0072, 0209SWH0073, 0209SWH0074, 0209SWH0075, 0209SWH0076, 0209SWH0077, 0209SWH0078, 0209SWH0079, 0211SWH0152, 0211SWH0153, 0211SWH0154, 0211SWH0155, 0211SWH0156, 0212SWH0210, 0212SWH0205, 0212SWH0206, 0212SWH0207, 0212SWH0208, 0212SWH0209, 0307SWH0035, 0308SWH0046, 0308SWH0047, 0309SWH0080, 0309SWH0081, 0309SWH0082, 0311SWH0157, 0311SWH0158, 0312SWH0211, 0312SWH0212, 0312SWH0213, 0312SWH0214, 0313SWH0234, 0313SWH0235, 0313SWH0236, 0408SWH0048, 0409SWH0083, 0409SWH0084, 0409SWH0085, 0409SWH0086, 0409SWH0087, 0409SWH0088, 0409SWH0089, 0409SWH0090, 0409SWH0091, 0409SWH0092, 0409SWH0093, 0409SWH0094, 0409SWH0095, 0409SWH0096, 0409SWH0097, 0409SWH0098, 0409SWH0099, 0411SWH0159, 0411SWH0161, 0412SWH0215,  0412SWH0216, 0507SWH0036, 0507SWH0037, 0507SWH0038, 0507SWH0039, 0508SWH0050, 0510SWH0118, 0510SWH0119, 0510SWH0120, 0510SWH0121, 0511SWH0162, 0511SWH0163, 0511SWH0164, 0512SWH0217, 0512SWH0218, 0512SWH0219, 0512SWH0220, 0512SWH0221, 0512SWH0222, 0613SWH0237, 0613SWH0238, 0613SWH0239, 0613SWH0240, 0613SWH0241, 0613SWH0242, 0613SWH0243, 0613SWH0244, 0613SWH0245, 0613SWH0246, 0613SWH0247, 0613SWH0248, 0613SWH0249, 0613SWH0250, 0708SWH0052, 0708SWH0053, 0709SWH0100, 0710SWH0122, 0710SWH0123, 0711SWH0165, 0711SWH0166, 0711SWH0167, 0711SWH0168, 0711SWH0169, 0711SWH0170, 0712SWH0223, 0712SWH0224, 0712SWH0225, 0805SWH0001, 0805SWH0002, 0805SWH0003, 0805SWH0004, 0806SWH0013, 0806SWH0014, 0806SWH0015, 0806SWH0016, 0808SWH0054, 0808SWH0055, 0808SWH0056, 0809SWH0101, 0810SWH0124, 0810SWH0125, 0810SWH0126, 0810SWH0127, 0812SWH0226, 0812SWH0227, 0812SWH0228, 0906SWH0017, 0907SWH0040, 0908SWH0057, 0908SWH0058, 0908SWH0059, 0908SWH0060,  0908SWH0061, 0908SWH0062, 0910SWH0128, 0910SWH0129, 0910SWH0130, 0910SWH0131, 0910SWH0132, 0910SWH0133, 0910SWH0134, 0910SWH0135, 0910SWH0136, 0910SWH0137, 0910SWH0138, 0910SWH0139, 0911SWH0171, 0911SWH0172, 0911SWH0173, 0911SWH0174, 0911SWH0175, 0911SWH0176, 0911SWH0177, 0911SWH0178, 0911SWH0179, 0911SWH0180, 0911SWH0181, 0911SWH0182, 0911SWH0183, 0911SWH0184, 1006SWH0018, 1006SWH0019, 1006SWH0020, 1006SWH0021, 1006SWH0022, 1006SWH0023, 1006SWH0024, 1007SWH0041, 1007SWH0042, 1007SWH0043, 1009SWH0102, 1009SWH0103, 1009SWH0104, 1009SWH0105, 1009SWH0106, 1009SWH0107,  1009SWH0108, 1009SWH0109, 1009SWH0110, 1009SWH0111,  1009SWH0112, 1009SWH0113, 1009SWH0114, 1011SWH0185, 1012SWH0229, 1012SWH0230, 1012SWH0231, 1012SWH0232, 1106SWH0025, 1106SWH0026, 1106SWH0027, 1106SWH0028, 1106SWH0029, 1106SWH0030, 1108SWH0063, 1108SWH0064, 1109SWH0115, 1110SWH0140, 1110SWH0141, 1111SWH0195, 1205SWH0005, 1205SWH0006, 1205SWH0007, 1209SWH0116, 1209SWH0117, 1210SWH0142, 1210SWH0144, 1210SWH0145, 1210SWH0146, and 1210SWH0147
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. || Used for assisting patients/residents to a standing position.
  • Manufacturer
    Ergosafe Products LLC DBA Prism Medical Services USA

Manufacturer

Ergosafe Products LLC DBA Prism Medical Services USA
  • 제조사 주소
    Ergosafe Products LLC DBA Prism Medical Services USA, 45 Progress Pkwy, Maryland Heights MO 63043-3701
  • 제조사 모회사 (2017)
    Triona Holding Sa
  • Source
    USFDA