Events

Device Recall WaterLase iPius 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biolase Technology 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
    68870
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2263-2014
  • 사례 시작날짜
    2014-06-12
  • 사례 출판 날짜
    2014-08-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128895
  • 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
    Powered laser surgical instrument - Product Code GEX
  • 원인
    Biolase is recalling the waterlase iplus dental laser system because of a discrepancy present in the user interface software (version 1.7). if an error occurs in the procedure screen, the air setting will change to 1% and off.
  • 조치
    An Urgent Medical Device Correction letter dated 6/12/2014 was sent to all customers who purchased the WaterLase iPlus Dental Laser System. The letter informs the customers of the problems identified and the actions to be taken. Customers are informed that a Field Service Engineer can install the software update. Customers with are instructed to contact Customer Service at (800) 321-6717.

Device

Device Recall WaterLase iPius
  • 모델명 / 제조번호(시리얼번호)
    Serial No.  72110047 72111060 72110077 72110128 72110263 72110281 72110286 72110343 72110469 72110836 72110940 72110983 72130260 72130263 72140014 72140033 72140034 72140036 72140037 72140038 72140041 72140042 72140045 72140046 72140047 72140048 72140052 72140054 72140057 72140058 72140059 72140060 72140061 72140063 72140064 72140066 72140068 72140070 72140072 72140078 72140110 72140111 72140083 72140114 72140165 72140176 72140126 72140129 72140129 72140130 72140136 72140139 72140140 72140141 72140144 72140145 72140152 72140153 72120052 72140039 72140077 72140079 72140090 72140127 72140131 72140133 72140148 72140177 72140051 72140053 72140055 72140056 72140073 72140074 72140075 72140085 72140076 72140154 72120057 72130195 72130540 72130631 72140132 72140112 72140067 72140128 72140071 72140087 72140089 72140086 72140084 72140088 72140123 72140106 72140107 72140146 72140108 72140137 72140122 72140134 72140124 72140115 72140116 72140117 72140118 72140119 72140120 72140121 72140091 72140092 72140095 72140096 72140097 72140098 72140099 72140125
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide in US and worldwide to: Canada, UK, Russia, Korea, Hong Kong, Libya, Iran, Iraq, Kuwait, Singapore, Armenia, Egypt, Pakistan, Sweden, New Zealand, Poland, Germany, Italy, UAE.
  • 제품 설명
    WaterLase iPlus Dental Laser System, Part No. 7200854-XX || Software Upgrade Kit, Part No. 6201463.
  • Manufacturer
    Biolase Technology Inc

Manufacturer

Biolase Technology Inc
  • 제조사 주소
    Biolase Technology Inc, 4 Cromwell, Irvine CA 92618-1816
  • Source
    USFDA