Events

Device Recall Maquet VOLISTA StandOP Surgical Light 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GETINGE US SALES LLC 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
    79583
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1349-2018
  • 사례 시작날짜
    2018-02-07
  • 사례 출판 날짜
    2018-04-10
  • 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=162696
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • 원인
    The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. in the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.
  • 조치
    The firm, Getinge, sent an "URGENT MEDICAL DEVICE RECALL" Notice dated 2/7/2018 to all affected consignees via mail. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following: 1) Ensure that all users of the device are made aware of this field correction. 2) Check the device serial number against the list of affected serial numbers. 3) Contact the recalling firm to arrange for servicing of all affected units. Getinge Customer Service: (800) 950-9912, 8AM - 5PM (EST) Monday to Friday. 4) Complete and sign the enclosed customer response form, and return it by fax to: (973) 860-1675 or by email to: VolistaLights.FA@getinge.com. If you have any questions, please contact your Getinge representative or call Getinge Customer Service at (800)950-9912 (Select option 1) between 8:00 AM and 5:00 PM (EST).

Device

Device Recall Maquet VOLISTA StandOP Surgical Light
  • 모델명 / 제조번호(시리얼번호)
    Model VLT600 SF AIM STP:  Ref Code: ARD568811901: Serial Numbers:  21001 21002 22000  Ref Code: ARD568811911: Serial Numbers: 25002 31000 31001 31002 31003 31004 31006 31008 31009 31010 31012 31017 31018 31019 31020 31021 31022 31023 31024 31025 31026 35000 35001 35011 35012 35013 35014 35015 35017 35018 35019 35020 35021 35022 35023 35024 35025 35026 35027 35028 35029 35030 35031 35032 35033 38000 38001 38002 38003 38005 38009 38011 38012 38013 38014 38015 38016 38017 38018 38019 38020 38021 38022 38023 38024 38025 38026 38027 500000 500001 500002 500003 500004 500005  Model VLT600 DF AIM STP:  Ref Code: ARD568811951 (Not in distribution in the U.S.) Serial Numbers: 20502 20503  Ref Code: ARD568811961 Serial Numbers: 25005 25006 25007 28003 28004 31000 31001 31002 31003 31004 31005 31006 31008 31009 31011 31012 31013 31014 31015 31016 31017 31019 31020 31030 31031 31039 31040 31041 31042 31043 31044 31045 31046 31047 31048 31049 31050 31051 31052 31053 31054 31055 31056 38025 38026 38027 38028 500001 500002
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, ID, IA, KS, KY, ME, MO, NE, NY, OR, TN, TX, UT, and WA; and countries of: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Ghana, Hong Kong, Hungary, India, Iran, Iraq, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad-Tobago, Turkey, UAE, UK, Yemen and Zimbabwe.
  • 제품 설명
    VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 || ARD568811951, ARD568811961 || The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.
  • Manufacturer
    GETINGE US SALES LLC

Manufacturer

GETINGE US SALES LLC
  • 제조사 주소
    GETINGE US SALES LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA