Events

Vantage Panoramic XRay System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Midmark Corp dba Progeny 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
    66603
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0651-2014
  • 사례 시작날짜
    2013-09-20
  • 사례 출판 날짜
    2014-01-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-12-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122704
  • 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
    System,x-ray,extraoral source,digital - Product Code MUH
  • 원인
    An error was identified in the real time controller (rtc) firmware versions 3.0, 3.1, 3.2, and 3.3 used in vantage panoramic x-ray systems. the error may cause the column of the vantage panoramic x-ray unit to continue moving vertically despite the release of the movement control button (i.E. failure to stop").
  • 조치
    An URGENT MEDICAL DEVICE FIELD CORRECTION letter dated September 20, 2013 was sent to all consignees. Letters sent to distributors include instructions on how to identify the defective units, to quarantine the machine(s), and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will either schedule an on-site field correction or arrange for the replacement of the affected device(s) depending on the customer's preference. Midmark further requested the distributors provide Midmark with the names, addresses, phone numbers, and e-mail addresses of any customers that purchased any defective units. Field corrections include the upgrading of RTC firmware to revision 3.4 on the defective units and will be performed as no additional charge by Midmark personnel. Letter sent to practitioners include instructions on how to identify the defective units, instructions on how to temporarily reduce the likelihood of the unintentional movement, and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will schedule an on-site field correction by upgrading the firmware to revision 3.4.

Device

Vantage Panoramic XRay System
  • 모델명 / 제조번호(시리얼번호)
    Vantage Panoramic X-Ray System firmware versions: 3.0, 3.1, 3.2, and 3.3.   Vantage Panoramic X-Ray System Catalog Numbers and Serial Numbers: Catalog Number V5000, Serial Numbers ZM81025, ZM81026, ZM81030, ZZ08005, ZZ08006, ZZ08007, ZZ08008, ZZ08009, ZZ08010, ZZ08011, ZZ08012, ZZ08013, ZZ08015, ZZ08016, ZZ08017, Z08018, ZZ08019, ZZ08020, ZZ08021, ZZ08022, ZZ08023, ZB51001, ZB51002, ZB51006, ZB51007, ZT18018, ZY49014, ZK58019, ZS54011, ZP01043, ZV78016, ZE09006, ZN44018, ZS59007, ZS59001, ZW15007, ZW34003, ZW34012, ZW34018, ZY49012, ZY49015, ZZ02010, ZM81022, ZS54012, ZE09019, ZM81017, ZT18004, ZT18015, ZN44020, ZE09012, ZM81023, ZT27012;  Catalog Number V5050, Serial Number ZZ08014;  Catalog Number V5100, Serial Numbers ZM81027, ZM81028, ZZ08003; Catalog Number V5150, Serial Number ZZ08002;  Catalog Number V5150C, Serial Number ZM81016
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, CA, CO, CT, FL, GA, IL, KS, MA, NC, NH, NJ, OH, OK, PA, SC, TN, TX, VA, and WI, and the countries of Australia, Canada, and Russia.
  • 제품 설명
    The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800
  • Manufacturer
    Midmark Corp dba Progeny Inc

Manufacturer

Midmark Corp dba Progeny Inc
  • 제조사 주소
    Midmark Corp dba Progeny Inc, 675 Heathrow Dr, Lincolnshire IL 60069-4206
  • 제조사 모회사 (2017)
    Midmark Corporation
  • Source
    USFDA