Device Recall Ultraview Digital Telemetry Transmitter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, Incorporated 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
    48985
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1652-2008
  • 사례 시작날짜
    2008-07-18
  • 사례 출판 날짜
    2008-09-18
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-03-21
  • 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
    Telemetry Reciever - Product Code DSI
  • 원인
    Telemetry modules are failing to alarm for low heart rate and asystole.
  • 조치
    On 07/18/08 Spacelabs Healthcare issued a "URGENT-MEDICAL DEVICE CORRECTION" letter, dated July 16, 2008, to all customers who received the Spacelabs Medical Telemetry Receiver-Model 90478. The letter states circumstances in which the alarm fails, how to test each module for high rate alarm prior to patient use and a temporary work around if the alarm failure exists.` Letters have a receipt acknowledgement to ensure each customer receives the letter. Spacelabs Technical Support will personally install the new software, version V3.05.07EN, in all Spacelabs Medical Telemetry Receivers Model 90478. Technical Support will also be responsible for responding to customer technical questions and ensuring each customer is upgraded regarding this medical device recall. For assistance contact SpaceLabs Medical at 1-425-657-7200.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers 478-111508, 478-111509, 478-111510, 478-111511, 478-111962, 478-111963, 478-111964, 478-111965 478-114831, 478-117016, 478-117395, 478-117602, 478-122332, 478-122333, 478-122535, 478-124039, 478-124040, 478-124042, 478-124055, 478-108923, 478-108924, 478-108925, 478-108926, 478-108927, 478-108928, 478-108929, 478-108930, 478-112419, 478-112420, 478-112421, 478-112422, 478-114943, 478-114944, 478-114945, 478-114946, 478-114947, 478-114948, 478-114949, 478-114950, 478-114951, 478-114952, 478-122698, 478-122704, 478-122711, 478-137602, 478-137603, 478-144927 478-122680, 478-122680, 478-122680, 478-122680, 478-128481, 478-128483, 478-128515, 478-128525, 478-112052, 478-113089, 478-113097, 478-113704, 470-110122, 478-110126, 478-110939, 478-110940, 478-113098, 478-113099, 478-113101, 478-120415, 478-122158, 478-122159, 478-122163, 478-124049, 478-124057, 478-124058, 478-124570, 478-124571, 478-124994, 478-124996, 478-113527, 478-113528, 478-113529, 478-113530, 478-113531, 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Internationally
  • 제품 설명
    Ultraview Digital Telemetry Transmitter, Model 90478 || The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, including asystole, ventricular fibrillation and ventricular tachycardia.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA