Events

Device Recall Jupiter, Mars, Titan, TruSystem and Saturn operating table systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Trumpf 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
    73103
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0759-2016
  • 사례 시작날짜
    2016-01-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143071
  • 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
    Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
  • 원인
    Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum trendelenburg position.
  • 조치
    TRUMPF Medical sent an Urgent Field Safety Information letter dated January 15, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed to take the following actions: Actions to be taken 1. Remove the patient transport Shuttle from operation. 2. Trumpf Medical, or a designated service representative, will schedule an appointment with the customer to perform service on the impacted device to prevent the issue from occurring. Passing along this information: Please make sure that, in your organization, all users of the patient transport Shuttle as well as any other personnel who must be informed, have been made aware of this safety information. If you have provided the device to third parties, please forward them a copy of this letter, or inform the contact person listed above. Please store this information at least until this measure has been completed. If you have any questions concerning this request or the procedure as outlined, please contact Trumpf Medical Systems, Inc. at 888-474-9359 For questions regarding this recall call 843-534-0606.

Device

Device Recall Jupiter, Mars, Titan, TruSystem and Saturn operating table systems
  • 모델명 / 제조번호(시리얼번호)
    Product: Shuttle 2.7, Material Number: 1254362, Serial Number Range: 100801175  101349420; Product: Shuttle 2.7 360, Material Number: 1459862, Serial Number Range: 100843669-101212847; Product: Shuttle 3.7, Material Number: 1254363, Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360, Material Number: 1459863, Serial Number Range: 100787418-101334652.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.
  • 제품 설명
    Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). || The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • 제조사 주소
    Trumpf Medical Systems, Inc., 1046 Legrand Blvd, Charleston SC 29492-7672
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA