Events

Straumann coDiagnostiX 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Straumann Manufacturing 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
    59797
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3184-2011
  • 사례 시작날짜
    2011-08-04
  • 사례 출판 날짜
    2011-09-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103755
  • 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, image processing, radiological - Product Code LLZ
  • 원인
    Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.
  • 조치
    Staumann USA notified accounts by an Urgent Field Safety Notice letter dated August 4, 2011 and delivered via Federal Express Delivery Service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review the letter, take appropriate actions, including completing and faxing the enclosed. Customer Confirmation Form. Straumann released a corrected software upgrade (coDiagnostiX 8.0.2.3672), which is available for download when users go online and activate current software. If the user does not have internet access a replacement CD can be ordered from Technical Support at 866 - 531 -7365. Questions should be directed to Technical Support Monday through Friday from 8:00 am to 8:00 pm Eastern Time.

Device

Straumann coDiagnostiX
  • 모델명 / 제조번호(시리얼번호)
    Software version 8.0 as listed below: listed are the affected articles. Internet Upgrade: 019,0385 @ Upgrade cDX 8 PPP (7+) 019,0386 @ Upgrade cDX 8 Station (7+) 019.0387 @ Upgrade cDx 8 coDoctor (7+) 019.0388 @ Upgrade cDX coDoctor (7+) > PPP 8 0'19.0389 @ Upgrade cDX codoctor (7+) > PPG 8 019.0390 @ Upgrade cDX coDoctor (7+) >Station 8 019.0391 @ Upgrade cDX PPP (7 +):> PPG 8 019.0392 @ Upgrade cDX PPP (7+):> Station 8 019.0393 @ Upgrade coDX PPP > Station 8 Offline Upgrades: 019.0378 Upgrade coDiagnostix 8 PPP (7-) 0'19.0379 Upgrade coDiagnostiX 8 Station (7-) 019.0380 Upgrade coDiagnostiX 8 coDoctor (7-) 019.0381 Upgrade coDoctor (7-) -> PPP 8 019.0382 Upgrade coDoctor (7-) -> PPG8 019.0383 Upgrade PPP (7-) -> PPG 8 019.0384 coDiagnostiX CD coDlagnostiX licenses: 019.0370 coDiagnostiX 8 PPP 019.0371 coDiagnostiX 8 PPG 0'19.0372 coDiagnostiX 8 Station, and  019.0373 coDiagnositX 8 coDoctor.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill. || Imaging processing System
  • Manufacturer
    Straumann Manufacturing Inc.

Manufacturer

Straumann Manufacturing Inc.
  • 제조사 주소
    Straumann Manufacturing Inc., 60 Minuteman Rd, Andover MA 01810-1008
  • Source
    USFDA