Events

Octopus 101 Perimeter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Haag-Streit USA 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
    63011
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2411-2012
  • 사례 시작날짜
    2012-08-17
  • 사례 출판 날짜
    2012-09-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-05-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112266
  • 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
    Perimeter, automatic, ac-powered - Product Code HPT
  • 원인
    The firm recalled the device after learning of a possible deviation in the stimulus luminance of the perimeter octopus 101.
  • 조치
    The firm, HAAG-STREIT USA, Inc., sent a "Field Safety Notice 2012-01/01" dated August 10, 2012 via certified mail or onsite visit to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make all users of the product and relevant personnel aware of this Field Safety Notice; forward a copy to third parties, if affected product has been passed on; keep this notice at least until the completion of the corrective measure, and complete and return the enclosed Confirmation of Receipt Form via fax to: 513-229-3867 or scanned and emailed to : fieldsafetynotice@haag-streit-usa.com. If you have any questions, call 513-336-7255.

Device

Octopus 101 Perimeter
  • 모델명 / 제조번호(시리얼번호)
    Model Octopus 101. SN: 119, 136, 165, 166, 221, 222, 225, 236, 243, 273, 277, 279, 370, 371, 392, 507, 541, 553, 570, 602, 603, 611, 620, 622, 661, 667, 668, 687, 690, 726, 741, 744, 794, 796, 1054, 1214, 1275, 1276, 1277, 1313, 1322, 1326, 1380, 1402, 1404, 1413, 1414, 1436, 1437, 1459, 1460, 1489, 1490, 1491, 1492, 1560, 1561, 1607, 1608, 1625, 1626, 1706, 1710, 1852
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AR, CA, CT, FL, GA, IA, IL, LA, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, SD, WA, WI, and WV; and to the countries of Jamaica, Puerto Rico, and Mexico.
  • 제품 설명
    Octopus 101 Perimeter; PeriTrend Software Analysis || A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
  • Manufacturer
    Haag-Streit USA Inc

Manufacturer

Haag-Streit USA Inc
  • 제조사 주소
    Haag-Streit USA Inc, 3535 Kings Mills Rd, Mason OH 45040
  • 제조사 모회사 (2017)
    Metall Zug Ag
  • Source
    USFDA