Device Recall ABL90 FLEX 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Radiometer America 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
    58273
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2112-2011
  • 사례 시작날짜
    2011-01-12
  • 사례 출판 날짜
    2011-04-28
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Electrode, ion specific, potassium - Product Code CEM
  • 원인
    Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their abl 90 analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. if the device operator/user ignores the error message and continues to obtain biased measuring results using the.
  • 조치
    The firm, Radiometer America, sent two Urgent "Medical Device Field Correction" letters issued on February 4, and on February 24th, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to replace the sensor cassette. In order to prevent this situation from occurring, the firm informed the customers in the recall/correction notification that they intend to upgrade all ABL 90 Flex analyzers to a new software version. The new software will perform a check during a normal system FLUSH in order to allow the analyzer to detect the bias and will notify the customer immediately of this condition and will automatically disable the cassette thus preventing further use. The letter goes on to remind the device customers that until such time as the software upgrade is installed, they should make sure to adhere to the procedures stated in the Reference Manual which call for the replacement of the sensor cassette immediately upon receiving message #1310. The letter further instructs the customer to complete and return the attached FAX RETURN FORM via fax to 440-871-0463. The letter also states that the expected release date for the new software should be sometime in the second half of February 2011. If you have any questions regarding this letter, or the upgrade, please contact Technical Support staff at 1-800-736-0600 Opt 4.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 393-090, all production runs for Serial Numbers: 393-090R0026N0010 to 393-090R0082N0005.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of CA, DC, PA, MN, NY, NJ, TX, OH, MO, WI, UT, and MI; and country of Canada.
  • 제품 설명
    ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. || The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • 제조사 모회사 (2017)
  • Source
    USFDA