Events

ReliaMed Deluxe Portable Adjusting Table 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MDC Acquisition Co. 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
    55772
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2288-2010
  • 사례 시작날짜
    2010-04-23
  • 사례 출판 날짜
    2010-08-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91751
  • 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
    Chair and table, medical - Product Code FPS
  • 원인
    Two complaints were received of the vinyl-covered, padded, plywood table surface breaking near the foot end.
  • 조치
    "Urgent: Medical Device Recall" letters were sent to consignees from Milliken Medical and Meyer Distributing Company in April 2010 describing the issue. They instructed their customers to immediately stop use of the table. customers were instructed to return the tables to the firm with an enclosed Recall Form for future replacement, or for replacement with a comparable table from another menufacturer at no cost, or for refund of the original cost of the device. Consignees may contact Meyer Distributing Company at 800-472-4221 and Milliken Medical at 800-532-1356.

Device

ReliaMed Deluxe Portable Adjusting Table
  • 모델명 / 제조번호(시리얼번호)
    The table do not bear lot or serial numbers; however there are two device identification numbers representative of two different colors. ZZRNT100BL (blue) ZZRMT100BLK (black)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA and WI, and the country of Canada.
  • 제품 설명
    ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.
  • Manufacturer
    MDC Acquisition Co.

Manufacturer

MDC Acquisition Co.
  • 제조사 주소
    MDC Acquisition Co., 8595 Milliken Ave Ste 101, Rancho Cucamonga CA 91730-4942
  • Source
    USFDA