Events

Device Recall Vital Sign elance Monitor, Model 93300 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
    59441
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2916-2011
  • 사례 시작날짜
    2011-07-06
  • 사례 출판 날짜
    2011-08-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102807
  • 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
    Patient Physiological Monitor (with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    Model 93300 vital signs monitor may stop operating while in use, and when this occurs, the monitor may also fail to power on. the resulting situation may cause a loss of monitoring for the patient.
  • 조치
    Spacelabs Healthcare, Llc sent an "Urgent-Medical Device Correction" letter dated 18 July 2011 to all affected customers. The letter notified the customers of the problem and recommended customers make their staff aware. It also informed them a Field Service Engineer will contact them to check, and if necessary make adjustments. Customers can contact Spacelabs Healthcare at 800-522-7025 and select 2 for Technical Support or outside the U.S. at +86512-8717-1888, extension 304.

Device

Device Recall Vital Sign elance Monitor, Model 93300
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 3300-000001, 3300-000002, 3300-000003, 3300-000005, 3300-000006, 3300-000007, 3300-000008, 3300-000009, 3300-000010, 3300-000011, 3300-000012, 3300-000013, 3300-000014, 3300-000015, 3300-000016, 3300-000017, 3300-000018, 3300-000019, 3300-000020, 3300-000021, 3300-000022, 3300-000023, 3300-000024, 3300-000026, 3300-000027, 3300-000028, 3300-000029, 3300-000030, 3300-000031, 3300-000032, 3300-000033, 3300-000034, 3300-000035, 3300-000036, 3300-000037, 3300-000038, 3300-000039, 3300-000040, 3300-000041, 3300-000042, 3300-000043, 3300-000044, 3300-000045, 3300-000046, 3300-000047, 3300-000049, 3300-000050, 3300-000052, 3300-000053, 3300-000054, 3300-000055, 3300-000056, 3300-000057, 3300-000058, 3300-000059, 3300-000060, 3300-000061, 3300-000062, 3300-000063, 3300-000064, 3300-000065, 3300-000066, 3300-000067, 3300-000068, 3300-000069, 3300-000070, 3300-000071, 3300-000072, 3300-000073, 3300-000074, 3300-000075, 3300-000076, 3300-000077, 3300-000078, 3300-000079, 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  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: (USA) Nationwide distribution including the state of WI, and the countries of Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Malaysia, Napel, Netherlands, Nicaragua, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Republic of Macedonia, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, Venezuela, and Vietnam.
  • 제품 설명
    Vital Sign elance Monitor, Model 93300 || Spacelabs Healthcare, Llc. || A vital signs patient monitor with arrhythmia detection.
  • 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