Events

Philips HeartStart XL+ Defibrillator 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems (USA) 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
    18773
  • 사례 시작날짜
    2015-07-06
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 원인
    Philips has identifed the following xl+ software and hardware issues:, , software:, * the xl+ may fail to complete the power on sequence and continuously reboot., * the xl+ may either fail to power up or may shut down unexpectedly., * the xl+ may have a software version that did not reset a fail-safe monitoring component which could cause a delay of therapy or pacing interruption., * the xl+ may fail to generate verbal prompts in aed mode., , hardware:, * the speaker may fail., * the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery., * the xl+ exceeds the allowable radiated emissions level for class b cispr11., * the xl+ ecg signal from leads could be lost and unrecoverable., * the xl+ spo2 signal may lose communication and cause the device to reboot., * the xl+ battery detection system may be disrupted and cause a false low battery alarm.
  • 조치
    Product to be modified

Device

Philips HeartStart XL+ Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    Model: 861290, Affected: Serial number ranges: USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA