Events

Device Recall Performa TM300 Traction System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sammons Preston Rolyan, An Ability One Company 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
    31492
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1444-05
  • 사례 시작날짜
    2005-07-13
  • 사례 출판 날짜
    2005-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-01-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37983
  • 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
    The traction device may malfunction, producing oscillation and a jerking motion.
  • 조치
    Sammons Preston Roylan, the U.S. agent for Ito Co., Ltd. issued recall letters dated 7/13/05 to all of their customers who purchased the Performa TM-300 traction unit, informing them that the manufacturer, Ito Co., Ltd., is recalling the units because the units may exhibit oscillation during some traction modes. The accounts were requested to contact Tina Kreisher at 1-800-323-5547, ext. 1383 if their TM-300 unit has a serial number that falls in the range listed in the recall letter. Tina will arrange for the unit to be shipped to the manufacturer's authorized repair center for upgrading of the software to version 2.8, and for the shipment of a loaner unit while their unit is being upgraded.

Device

Device Recall Performa TM300 Traction System
  • 모델명 / 제조번호(시리얼번호)
    Product No. A501-009, serial numbers 1000 through 1207
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia
  • 제품 설명
    TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan
  • Manufacturer
    Sammons Preston Rolyan, An Ability One Company

Manufacturer

Sammons Preston Rolyan, An Ability One Company
  • 제조사 주소
    Sammons Preston Rolyan, An Ability One Company, 4 Sammons Ct, Bolingbrook IL 60440-4995
  • Source
    USFDA