Events

Device Recall CareVue Chart 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    51982
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1436-2009
  • 사례 시작날짜
    2009-05-05
  • 사례 출판 날짜
    2009-05-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81825
  • 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
    Medical Cathode-Ray Tube Display - Product Code DXJ
  • 원인
    Software: a software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period.
  • 조치
    Philips Medical notified accounts by letter on 5/6/09 the Urgent - Medical Device Correction notification. While customers await the correction of their devices, customers are given the following instructions: Clinicians should not rely solely on the worklist within CareVue Chart to determine actionable orders for the patient until their software is upgraded. Clinical users should always use the medication administration record (MAR) and the administration record in determining the care their patients receive in addition to the critical care worklist. Philips is currently developing a correction that will be available at no additional charge. A Philips representative will notify customers when the software correction becomes available. If further assistance is needed, customers are to contact the Philips Customer Care Center at 1-800-722-9377.

Device

Device Recall CareVue Chart
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 4621A00101, 4621A00102, 4621A00103, 4621A00104, 4621A00105, 4621A00106, 4621A00107, 4621A00108, 4621A00109, 4621A00110, 4621A00111, 4621A00112, 4621A00113, 4621A00114, 4621A00115, 4621A00116, 4621A00117, 4621A00118, 4621A00119, 4621A00120, 4621A00121, 4621A00122, 4621A00123, 4621A00124, 4621A00125, 4621A00126, 4621A00127, 4621A00128, 4621A00129, 4621A00130, 4621A00131, 4621A00132, 4621A00133, 4621A00134, 4621A00135, 4621A00136, 4621A00137, 4621A00138, 4621A00139, 4621A00140, 4621A00141, 4621A00142, 4621A00143, 4621A00144, 4621A00145, 4621A00146, 4621A00147, 4621A00148, 4621A00149, 4621A00150, 4621A00151, 4621A00152, 4621A00153, 4621A00154, 4621A00155, 4621A00156, 4621A00157, 4621A00158, 4621A00159, 4621A00160, 4621A00161, 4621A00162, 4621A00163, 4621A00164, 4621A00165, 4621A00166, 4621A00167, 4621A00168, 4621A00169, 4621A00170, 4621A00171, 4621A00172, 4621A00193, 4621A00194, 4621A00195, 4621A00196, 4621A00197, 4621A00198, 4621A00199, 4621A00200, 4621A00201, 4621A00202, 4621A00203, 4621A00204, 4621A00205, 4621A00206, 4621A00207, 4621A00208, 4621A00209, 4621A00210, 4621A00211, 4621A00213, 4621A00214, 4621A00217, 4621A00218, 4621A00219, 4621A00220, 4621A00221, 4621A00222, 4621A00223, and  4621A00224.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including states of CA, FL, MA, OH, OK, RI, VT, and WV and countries of Canada, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and the United Kingdom.
  • 제품 설명
    CareVue Chart Release C.O || Part Number: 862246 || Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA