Events

Device Recall RIO Robot Arm Interactive Orthopedic 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
    58162
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0146-2012
  • 사례 시작날짜
    2011-01-20
  • 사례 출판 날짜
    2011-11-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98566
  • 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
    Orthopedic stereotaxic instrument - Product Code OLO
  • 원인
    Mako surgical corp. is recalling their rio robotic arm interactive orthopedic system (rio) due to software issue that exist that could potentially result in a bone resection. no adverse events reported.
  • 조치
    The firm, MAKO Surgical Corp., sent an "RECALL NOTICE 2.4. SITES" letter dated February 1, 2011 to its customers. The letter describes the product, problem, actions to be taken which includes a workaround and an updated user guide identifying the appropriate workflow. The customers were instructed to follow the user guide and workflow and to complete and return the enclosed confirmation memo to their MAKOplasty Specialist or return it in the pre-addressed, pre-paid envelope provided. MAKOplasty included with the letter new steps in the surgical workflow in the use of the RIO system to ensure error value accuracy; worked on a software update that will not allow the user to proceed with error values that do not support the required accuracy-this software was to be supplied to customers in February 2011, and trained MAKOplasty Specialist will make available written updates to the RIO use instructions as well. If you have any questions or concerns, please do not hesitate to speak with your MAKOplasty Specialist or contact the Manager of Customer Relations at 954.927.4022 x447.

Device

Device Recall RIO Robot Arm Interactive Orthopedic System
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: ROB034, ROB035, ROB036, ROB037, ROB038, ROB042, ROB044, ROB045, ROB046, ROB047, ROB048, ROB049, ROB050, ROB051, ROB053, ROB054, ROB055, ROB056, ROB057, ROB059, ROB060, ROB061, ROB062, ROB062, ROB063, ROB066, ROB067, ROB069, ROB070, ROB071, ROB072, ROB073, ROB074, ROB075, ROB076, ROB077, ROB078, ROB079, ROB080, ROB081, ROB082, ROB083, ROB084, ROB085, ROB086, ROB088, ROB093, ROB094, ROB096, ROB097, ROB098, ROB099, ROB100, ROB101, ROB102, ROB103, ROB104, ROB107, ROB108, ROB109, ROB110, ROB112, ROB114, ROB116, ROB117, ROB118, ROB120, ROB121, ROB122, ROB123, ROB124.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: AZ, CA, CO, FL, GA, IA, IL, LA, MI, MO, MS, NC, NJ, NV, NY, OK, OH, OR, PA, RI, TX, UT, VA, WA, WI, and WV; and countries of: Scotland, Italy and Korea.
  • 제품 설명
    Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995 UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 DAVIE ROAD, FT. LAUDERDALE, FL 33317. || RIO System - 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. The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be approriate, and where reference to rigid anatomical bony structures can be identified relative to a CT base model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

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