Device Recall Sechrist Low Profile Wheeled Stretcher 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sechrist Industries 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
    71455
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1939-2015
  • 사례 시작날짜
    2015-06-01
  • 사례 출판 날짜
    2015-07-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-10-20
  • 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
    Stretcher, wheeled - Product Code FPO
  • 원인
    Sechrist industries is recalling the sechrist low profile wheeled stretcher because it may experience an unexpected incline angle during the height adjustment of the low profile wheeled stretcher when lifting the patient upward or when lowering the wheeled stretcher to a height at which the patient can be loaded/unloaded.
  • 조치
    Seachrist sent an Urgent: Medical Device Correction letter dated June 1. 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate the Sechrist Low Profile Wheeled Stretcher identified in the attached serial number list (Attachment A) are affected by the field correction and are located at your facility. Within the following weeks, a Sechrist trained Field Service Technician will schedule a visit to your facility to install a Hydraulic Wheeled Stretcher Alignment kit which will greatly minimize the degree of the incline angle that can be experienced after it is installed. Customers are informed that within the following weeks, a Sechrist trained Field Service Technician will schedule a visit to their facility to install a Hydraulic Wheeled Stretcher Alignment kit which will greatly minimize the degree of the incline angle that can be experienced after it is installed. For further questions, please call: (714) 579-8318, or (714) 579-8311. We apologize for any disruption that this correction may cause. Sechrist is dedicated to ensuring the safety and quality of our products. If you have any questions about what to do, please contact us.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Code: 0086 0088 0024 0054 0056 0031 0040 0085 0046 0051 0121 0042 0032 0036 0021 0022 0015 0020 0065 0074 0066 0069 0007 0017 0005 0018 0004 0008 0062 0063 0038 0043 0033 0035 0037 0058 0071 0010 0011 0019 0049 0050 0055 0023 0039 0045 0059 0064 0028 0041 0044 0025 0001 0014 0068 0073 0057 0060 0027 0029 0030 0082 0083 0048 0070 0072 0034 0047 0009 0013 0080 0002 0081 0090 0091   Item No. 21762-135-33HJ 21762-135-33HJ 21762-135-33HJ 21762-135-33HJ 21762-135-33HJ 21762-110-36H
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution and Internationally to Japan and Jordan.
  • 제품 설명
    Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-41H, || 21762-111-36H.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Sechrist Industries Inc, 4225 E La Palma Ave, Anaheim CA 92807-1815
  • 제조사 모회사 (2017)
  • Source
    USFDA