Events

Device Recall LCSU 4 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Laerdal Medical Corporation 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
    76744
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1873-2017
  • 사례 시작날짜
    2017-01-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154075
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • 원인
    The on/off functionality in the lcsu 4 is controlled by electronic components, one of which might be damaged.
  • 조치
    On January 8, 2017 Laerdal Medical distributed Urgent Device Recall Notification Letters to their customers thru Stericycle. The documents were dispatched via standard UPS ground delivery. Laerdal Medical has discovered that the LCSU4 may turn on by itself when connected to a power source and/or may not be able to be turned off with the on/off button without removing the battery or external power source. You can continue to use your suction units until your replacement arrives by following the steps: Exception: Some LCSU 4 units have a RW label on the bottom. These units have been reworked by Laerdal Medical and are not affected by this Field Safety Notice, even if they have manufacturing dates within the 20150501 to 20161028 range. **Check On/Off functionality** You can run a quick test to identify if the unit has failing On/Off functionality: Turn unit on; Turn unit off again. If the unit cannot be turned off using the On/Off button, the unit contains a damaged component. The device should be taken out of service. The safety and effectiveness of the device is not affected by the failure of the On/Off button as long as it has power. Note that even if the unit passes this test, the problem may occur later. The actions below must be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit. **Actions to be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit** You can continue to use your LCSU 4 unit until you receive a replacement unit, but it is recommended to implement the following extra safety measures: Store the LCSU 4 unit without the battery connected so that it cannot turn on by itself. Perform routine checks of the On/Off functionality by turning the unit on and off using the On/Off button. All units with failing On/Off functionality should be removed from service. ** Actions to be taken if the On/Off functionality fails during clinical use** If the On/Off functionality fai

Device

Device Recall LCSU 4
  • 모델명 / 제조번호(시리얼번호)
    Affected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), ¿ 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) || & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)
  • Manufacturer
    Laerdal Medical Corporation

Manufacturer

Laerdal Medical Corporation
  • 제조사 주소
    Laerdal Medical Corporation, PO Box 1840, 167 Myers Corners Rd, Wappingers Falls NY 12590-3869
  • 제조사 모회사 (2017)
    Laerdal Medical Corporation
  • Source
    USFDA