Events

Device Recall Arthrex Shoulder Suspension Tower 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Allen Medical Systems, 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
    76257
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1198-2017
  • 사례 시작날짜
    2017-01-03
  • 사례 출판 날짜
    2017-02-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152596
  • 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
    Apparatus, traction, non-powered - Product Code HST
  • 원인
    During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.
  • 조치
    The distributor was notified of the recall via email on January 3, 2017. The letter identified the affected product, problem and actions to be taken. The letter instructs the consignee to remove the product from service and follow instructions to return the device to Allen Medical for repair.

Device

Device Recall Arthrex Shoulder Suspension Tower
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 501798, 501799, 501800, 501801, 501802, 501803, 501804, 501805, 501806, 501807, 501808, 501809, 501810, 501811, 501812, 501813, 501814, 501815, 501816, 501817, 501818, 501819, 501820, 501821, 501822, 501823, 501824, 501825, 501826, 501827, 501828, 501829, 501830, 501831, 501832, 501833, 501834, 501835, 501836, 501837, 501838, 501839, 501840, 501841, 501842, 501848, 501849, 501850, 501851, 501852, 501853, 501854, 501855, 501856, 501857, 501863, 501864, 501865, 501866, 501867, 501868, 501869, 501870, 501871, 501872, 501878, 501879, 501880, 501881, 501882, 501883, 501884, 501885, 501886, 501887, 501888, 501889, 501890, 501891, 501892, 501893, 501894, 501895, 501896, 501897, 510733, 510734, 510735, 510736, 510737, 510738, 510739, 510740, 510741, 510742, 510743, 510744, 510745, 510746, 510747, 510748, 510749, 510750, 510751, 510752, 510834, 510835, 510836, 510837, 510838, 510839, 510840
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US state of FL
  • 제품 설명
    Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 || Product Usage: || The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.
  • Manufacturer
    Allen Medical Systems, Inc.

Manufacturer

Allen Medical Systems, Inc.
  • 제조사 주소
    Allen Medical Systems, Inc., One Post Office Square, Acton MA 01720
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA