Events

Precision Ice 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pro Trainers' Choice Company 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
    58770
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2659-2011
  • 사례 시작날짜
    2011-04-18
  • 사례 출판 날짜
    2011-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100276
  • 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
    Pack (hot/cold) water circulating - Product Code ILO
  • 원인
    The control panel of the precision ice one patient use control unit and wrap system has a overheating issue. the control panel printed circuit boards were missing a jumper connection across resistors r28 a, b, c, and d.
  • 조치
    Pro Trainers' Choice sent a Mandate-Medical Device Recall on April 18, 2011 and April 20, 2011 to all affected costumers. The letter included a description of the product, affected model and lots. It instructed the costumers to discontinue using the Precision Ice, Model 4BBK02BK until the device is returned and corrected by Pro Trainers' Choice. The device should be returned to PO Box 27, Kingston, WA 98346. The customers were instructed to notify their sub-account customers of this recall if the devices were further distributed. Customers can call Pro Trainers' Choice Company at 360-297-3902 or visit the website www.precisionice.com for any questions about this recall.

Device

Precision Ice
  • 모델명 / 제조번호(시리얼번호)
    The affected serial numbers range from 100116 to 100452.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution including CA, CO, FL, IN, KS, NY, OR, TX, and WI.
  • 제품 설명
    Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). || The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. || The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***info@precisionice.com***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". || The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". || The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". || The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".
  • Manufacturer
    Pro Trainers' Choice Company

Manufacturer

Pro Trainers' Choice Company
  • 제조사 주소
    Pro Trainers' Choice Company, PO BOX 27, 26129 Calvary Lane NE, Suite 200, Kingston WA 98346
  • Source
    USFDA