Events

Device Recall ARIATELE TELEMETRY TRANSMITTER, Model 96281 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs 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
    69125
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2586-2014
  • 사례 시작날짜
    2014-07-02
  • 사례 출판 날짜
    2014-09-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129684
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    The transmitter display and the telemetry central station display may show a spo2 value when the sensor is not connected to the patient or in certain sensor failed conditions. this is an expansion of recall z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.
  • 조치
    Spacelabs notified both consignees via email of the expanded recall July 2, 2014. A f/u letter was sent by overnight delivery to the single new consignee the same day. Spacelabs sent an announcement of the expanded recall to both consignees identified in the expanded recall August 25, 2014. A field service technician from Spacelabs will visit each consignee and upgrade the software as necessary. If you have any questions about this corrective action program, please contact SpaceLabs Healthcare at 1-800- 522-7025, and select 2 for Technical Support.

Device

Device Recall ARIATELE TELEMETRY TRANSMITTER, Model 96281
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, and 6281-003056.  Model 96281, with SpO2 Option C.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to TX.
  • 제품 설명
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • 제조사 주소
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA