Events

Device Recall FOCUS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Instrumentarium Dental, PaloDEx Group Oy 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
    67342
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1091-2014
  • 사례 시작날짜
    2014-01-14
  • 사례 출판 날짜
    2014-02-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-05-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125292
  • 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
    Unit, x-ray, extraoral with timer - Product Code EHD
  • 원인
    Instrumentarium dental has delivered a number of focus 3.0 intraoral x-ray units in november 2013 with a potential flaw in the mounting hardware. a number of wall mount units were delivered with focus x-ray machines that had not been properly welded at our supplier. as a result of the incomplete welding operation, the wall mount unit on the focus x-ray unit may not properly support the unit as exp.
  • 조치
    The firm, Instrumentarium, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 14, 2014 was sent to all PaloDEx direct accounts (including subsidiaries). The letter inested recipients to perform a field inspection on potentially defective FOCUS 3.0 X-ray units (units with serial numbers F21221 - F21641 and F21643). If a defective wall mount is discovered during the inspection, the FOCUS X-ray unit must be taken out of service and the wall mount replaced before continuing use of the device. Replacement wall mounts will be made available free of charge for the field repair. A Technical Bulletin including instructions on how to perform the inspection was included with the letter. Direct accounts were further instructed to return the enclosed Acknowledgement Letter confirming receipt of the URGENT MEDICAL DEVICE RECALL letter by mail to Instrumentarium Dental, Jussi Tanskanen, Nahkelantie 160, Fl-04300 Finland; or, via e-mail to Jussi.tanskanen@instrudental.com. The direct accounts are to complete and return the enclosed Confirmation Letter to document that all of the potentially affected units have been inspected and repaired if necessary to Instrumentarium Dental, Jussi Tanskanen, Nahkelantie 160, Fl-04300 Finland; or, via e-mail to Jussi.tanskanen@instrudental.com. A nearly identical URGENT MEDICAL DEVICE RECALL letter dated January 22, 2014 was sent to all US customers. The instructions were the same as noted above in the January 14, 2014 letter to PaloDEx direct accounts. If there are any questions, do not hesitate to contact us at the following: Marketing Director, General dentistry Mika.anttila@instrudental.com Tel. +358 40 768 3340 For more information you can contact also: Director, Quality and Regulatory Affairs Tarja.paivinen@instrudental.com Tel. +358 40 719 0513 After sales Manager Mika.Kyllonen@instrudental.com Tel. + 358 40 080 5305

Device

Device Recall FOCUS
  • 모델명 / 제조번호(시리얼번호)
    Device Model Number / Sales Code: 50600-IMG;   Serial Numbers (US and Foreign): F21221 - F21641, and F21643;   Serial Numbers (US Devices): F21221 - F21230, F21265 - F21270, F21273 - F21290, F21296 - F21350, F23154 - F21365, F21367 - F21391, F21395 - F21447, F21451 - F21464, F21469 - F21478, F21481 - F21486, F21490 - F21519, F21525 - F21542, F21545 - F21550, F21565 - F21588, F21623 - F21628, F21636 - F21641, and F21643
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) including states of: AK, AZ, CA, CO, GA, IL, KY, MD, MT, NC, NV, OR, PA, TN, TX, UT, VA, WA,and WI; and Internationally to: Belgium Brazil, Chile, China, Czech Republic, France, Germany, Italy, Spain, Sweden, Switzerland, and United Kingdom.
  • 제품 설명
    The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. || FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
  • Manufacturer
    Instrumentarium Dental, PaloDEx Group Oy

Manufacturer

Instrumentarium Dental, PaloDEx Group Oy
  • 제조사 주소
    Instrumentarium Dental, PaloDEx Group Oy, Nahkelantie 160, Tuusula Finland
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA