Events

Device Recall Spacelabs Healthcare Ventilator Flexport Interface 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
    68374
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1824-2014
  • 사례 시작날짜
    2014-05-09
  • 사례 출판 날짜
    2014-06-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127487
  • 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
    Oximeter - Product Code DQA
  • 원인
    Spacelabs healthcare is voluntarily recalling the hamilton galileo ventilator flexport, model 90436a-07, where the monitored minute volumes (vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
  • 조치
    Spacelabs changed their strategy for updating the software and sent the updated letter Urgent-Medical Device Correction- Hamilton Galileo Ventilator Flexport Model 90436A-07, dated 10 June 2015, to their consignees. The firm is going to send consignees new replacement flexport(s) with upgraded software and requested consignees to return old affected units via Return Goods Authorization (RGA) to Spacelabs and the firm will destroy affected units. Consignees are instructed to take the following actions: 1. Please replace the affected devices and test for correct operation. 2. Return your old device(s) using the RGA number and prepaid FedX shipping label. Use the Reference code: and FedEx Return number: RETURN ADDRESS: Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 (425) 363-5816 If you have any questions about this corrective action program, please call Spacelabs Healthcare at (800) 522-7025 and select 2 for Technical Support. ********************************************************************************************** Spacelabs recommends that customers immediately advise their staff of this situation and if they continue to use the Flexport, to please keep in mind: 1) Galileo Interface Protocol (GIP) version 1.0 and 1.1 do not affect the flexport readings. Only GIP version 1.2 is an issue. 2) If you have the GIP version 1.2: -The ventilator alarms continue to work normally at the bedside and central station. -The ventilator itself is available and working correctly. -The reported x10 volumes would be an obvious error to the clinician. Spacelabs Field Service personnel will be contacting all customers to schedule a convenient time to install, at no cost, a software update that resolves this issue.

Device

Device Recall Spacelabs Healthcare Ventilator Flexport Interface
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers Distributed in the US:  436A000660, 436A000663, 436A000664, 436A000666, 436A000667, 436A000669, 436A004306, 436A004307, 436A004308, 436A004309, 436A004310, 436A006122, 436A006123, 436A006441, 436A006442, 436A006443, 436A006444, 436A006452, 436A006573, 436A006589, 436A006590, 436A006591, 436A006592, 436A006593, 436A006594, 436A006595, 436A006596, 6A006597, 436A006598, 436A006599, 436A006600, 436A006601, 436A00670, 436A006966 436A01020, 436A02086, 436A02087, 436A02088, 436A02234, 436A02246, 436A02247, 436A02281, 436A02282, 436A02283, 436A03237 and 436A03238.   Serial Numbers Distributed Outside the US: 436A003628, 436A003629, 436A003630, 436A003631, 436A003632, 436A003633, 436A003634, 436A003635, 436A003636, 436A003637, 436A003638, 436A003639, 436A003640, 436A003644, 436A003645, 436A003646, 436A003647, 436A004162, 436A004166, 436A004197,  436A004198, 436a005205, 436a005471, 436a005472, 436A005638, 436A005641, 436A005642, 436A006087, 436A006088, 436A006151, 436A006193, 436A006248, 436A006249, 436A006250, 436A006262, 436A006389, 436A006390, 436A006397, 436A006445, 436A006446,  436A006522, 436A006523, 436A006524, 436A006570, 436A006571, 436A006572, 436A006609, 436A006610, 436A006611, 436A006612, 436A006613, 436A006614, 436A006616, 436A006617, 436A006618, 436A006619, 436A006620, 436A006621, 436A006624, 436A006625,  436A006950, 436A006951, 436A01023, 436A01094, 436A01095, 436A01096, 436A01097, 436A01098, 436A01099, 436A01100, 436A01101, 436A01102, 436A01103, 436A01104, 436A01105, 436A01106, 436A01107, 436A01108, 436A01129, 436A01152, 436A01190, 436A01191, 436A01192, 436A01193, 436A01194, 436A01195, 436A01197, 436A01199, 436A01200, 436A01212, 436A01213, 436A01217, 436A01298, 436A02023, 436A02024, 436A02025, 436A02026, 436A02027, 436A02188, 436A02233, 436A02262, 436A02264, 436A02590, 436A02591, 436A02592, 436A03193, 436A03239, and 436A03500.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
  • 제품 설명
    Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
  • 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