Events

Device Recall Victory 9 with Power Seat 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pride Mobility Products Corp 에 의해 제조된 제품과 관련되어 있습니다.

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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
    57350
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1941-2012
  • 사례 시작날짜
    2010-11-26
  • 사례 출판 날짜
    2012-07-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95926
  • 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
    Vehicle, motorized 3-wheeled - Product Code INI
  • 원인
    The main harness connector was manufactured without the required back shield sealing protection. as a result, there is the potential for water to seep through the nonconforming harness.
  • 조치
    Three (3) pieces of information was distributed in the notification. They are: (1) Letter of Correction to the Provider (2) Letter of Correction for the Consumer (provider to issue to consumer) (3) Product Insert for Victory 9 Controller Interface Harness Replacement. The letter of Correction for Victory 9 with Power Sear (SC609PS), dated November 2010, identified the affected product and the reason for the correction. Customers were to record the serial number(s) and contact their provider's office to make an appointment to have the harness replaced.

Device

Device Recall Victory 9 with Power Seat
  • 모델명 / 제조번호(시리얼번호)
    SC609PS SD514509149FV0 SD514609080FV0 SD514609059FV0 SD514509207FV0 SD514509251FV0 SD514609113FV0 SD514609133FV0 SD514509186FV0 SD514509246FV0 SD520809132FV0 SD514609024FV0 SD514509188FV0 SD514609020FV0 SD502010082030 SD502010080030 SD502010084030 SD514509181FV0 SD514509240FV0 SD514609141FV0 SD514609030FV0 SD525409018030 SD514609005FV0 SD514609007FV0 SD514509194FV0 SD514609119FV0 SD514509222FV0 SD514609135FV0 SD520809138FV0 SD520809037FV0 SD514509211FV0 SD514609009FV0 SD514509197FV0 SD514509164FV0 SD514509223FV0 SD514509195FV0 SD514609067FV0 SD514609034FV0 SD514509210FV0 SD514609081FV0 SD520809048FV0 SD514509171FV0 SD520809076FV0 SD514509153FV0 SD514509156FV0 SD514509160FV0 SD514509231FV0 SD514509250FV0 SD514509157FV0 SD514509151FV0 SD514509150FV0 SD514609112FV0 SD514509169FV0 SD514609106FV0 SD514609087FV0 SD514609116FV0 SD514509176FV0 SD514609120FV0 SD514609013FV0 SD514609118FV0 SD514509274FV0 SD526409032030 SD514609102FV0 SD514609027FV0 SD514609041FV0 SD514609051FV0 SD514609134FV0 SD514509199FV0 SD514609083FV0 SD514609049FV0 SD514609055FV0 SD514609077FV0 SD514509203FV0 SD514509249FV0 SD514509183FV0 SD514509189FV0 SD520809119FV0 SD514609076FV0 SD514509158FV0 SD514509184FV0 SD514609084FV0 SD514509147FV0 SD520809042FV0 SD514509201FV0 SD514609026FV0 SD514509258FV0 SD533509010030 SD514609125FV0 SD514509154FV0 SD514609074FV0 SD514609054FV0 SD514609057FV0 SD520809134FV0 SD514609075FV0 SD514609008FV0 SD514509255FV0 SD514509187FV0 SD514609052FV0 SD514609079FV0 SD514509200FV0 SD514509272FV0 SD514609111FV0 SD514609082FV0 SD514609115FV0 SD514609021FV0 SD514609017FV0 SD514609035FV0 SD514609038FV0 SD514609063FV0 SD514509213FV0 SD514609062FV0 SD514509218FV0 SD514609060FV0 SD514509202FV0 SD514609036FV0 SD514509206FV0 SD514609031FV0 SD514509185FV0 SD514509152FV0 SD514609091FV0 SD514609100FV0 SD514609064FV0 SD514609045FV0 SD514509248FV0 SD514609129FV0 SD514509172FV0 SD514609128FV0 SD514609016FV0 SD514609117FV0 SD514509216FV0 SD514509268FV0 SD514609033FV0 SD514509148FV0 SD514609140FV0 SD520809113FV0 SD514609109FV0 SD514609056FV0 SD502110014030 SD514609122FV0 SD514609043FV0 SD520809136FV0 SD514509196FV0 SD514609078FV0 SD514509205FV0 SD514509243FV0 SD514509275FV0 SD520809041FV0 SD514509229FV0 SD527409028030 SD514609126FV0 SD514609085FV0 SD514609138FV0 SD514609006FV0 SD520809100FV0 SD514609028FV0 SD514609010FV0 SD526509020030 SD526509018030 SD514509271FV0 SD514509177FV0 SD514609061FV0 SD514509198FV0 SD514509266FV0 SD514509232FV0 SD514509233FV0 SD514609094FV0 SD514609073FV0 SD520809081FV0 SD514509182FV0 SD514509242FV0 SD514609086FV0 SD514509190FV0 SD514509212FV0 SD514609105FV0 SD514609023FV0 SD514609029FV0 SD514509173FV0 SD514609002FV0 SD514509204FV0 SD514509170FV0 SD514609107FV0 SD514509238FV0 SD514609019FV0 SD514509163FV0 SD536409020030
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Victory 9 with Power Seat (SC609PS) || Motorized wheelchair with elevating seat.
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

Pride Mobility Products Corp
  • 제조사 주소
    Pride Mobility Products Corp, 182 Susquehanna Ave, Exeter PA 18643
  • 제조사 모회사 (2017)
    Pride Mobility Products Corp
  • Source
    USFDA