Events

Device Recall Cable Assembly for the RIO STANDARD SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mako Surgical 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
    53033
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0064-2010
  • 사례 시작날짜
    2009-07-17
  • 사례 출판 날짜
    2009-10-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-05-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84483
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • 원인
    Cables fail to provide adequate transmission. mako surgical corporation is recalling 200996 cable assembly, hybrid extended length; 200997 cable assembly, hybrid, guidance module; and 200998 cable assembly, hybrid, ui panel. these parts are sub components of the 20300 rio standard system.
  • 조치
    A Recall Notice, dated July 15, 2009, was sent to owners of the RIO system (hospital OR staff) with a signed acknowledgement returned to MAKO. Surgeons using the RIO system during the recall time period, regardless of whether their system has already been upgraded, are given the notification letter and asked to sign and return the acknowledgement memo. The letter stated that customers' RIO will be upgraded to replace the potentially faulty cable with a new cable. Their MAKOplasty Specialist (MPS) will notify them when their system was scheduled to have their fiber optic cable upgrade. The upgrade will be installed by a Field Service Engineer (FSE) free of charge and the RIO will be completely tested prior to being returned to service. Customers should direct questions or concerns to their MPS, FSE, or Jim Pomeroy, who can be reached at 954-927-2044.

Device

Device Recall Cable Assembly for the RIO STANDARD SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: ROB031 through ROB068.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    200996-Cable Assembly, Hybrid Extended Length, || 200997 Cable Assembly, Hybrid, Guidance Module, || 200998 Cable Assembly, Hybrid, UI Panel || Subcomponents for the 203000 RIO STANDARD SYSTEM || Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. || All three cables are integral components and are not purchased separately. || However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . || The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

Mako Surgical Corporation
  • 제조사 주소
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Davie FL 33317-7424
  • Source
    USFDA