Events

Device Recall Ultraview SL Command Module 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, Llc 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
    60593
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0690-2012
  • 사례 시작날짜
    2011-11-03
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105892
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • 원인
    Nibp pump inside the ultraview sl command module, model 91496, became loose. the pump is suspended by the air hoses and electrical connections, but there can be enough movement to damage internal components and cause the module to fail.
  • 조치
    SpaceLabs Healthcare sent a Urgent Field Safety Notice dated November 28, 2011, return receipt requested to all US customers. The letter identified the product the problem and the action needed to be taken by customer. On December 6, 2011, SpaceLabs will send a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Records of notification will be maintained to ensure complete notification. Customers were instructed If you hear an unusual rattling noise, tag the module, set it aside and contact your Spacelabs field service engineer. Your field service engineer will be contacting you early in 2012 to schedule a mutually agreeable time to upgrade all of your affected modules. Upgrades will be performed on-site and at no cost to you. For any questions about this corrective action program, please call Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support or, outside the United States, 1-425-657-7200 x5089.

Device

Device Recall Ultraview SL Command Module
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide)
  • 제품 설명
    Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. || The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA