Events

TAPSCOPE 550 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiocommand Inc. 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
    58302
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0072-2012
  • 사례 시작날짜
    2010-10-25
  • 사례 출판 날짜
    2011-10-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100501
  • 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
    System, esophageal pacing - Product Code LPA
  • 원인
    Cardiocommand, inc. is recalling their tapscope 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ecg.
  • 조치
    On October 25, 2010, an Urgent Medical Device Recall Notice was sent by certified mail to all facilities advising them of the recall. The letter identified the affected product and reason for the recall. Users were asked to discontinue use and return the affected product to the firm. If all product was already used, then this should be indicated on the form provided. The firm will send replacement product in quantities equal to the returned product. The attached form should be completed and returned via fax. Customers were instructed to report any suspected incidents related to this issue to CardioCommand Customer Service at 1-800-231-6370. Also questions or comments should be directed to CardioCommand Customer Service.

Device

TAPSCOPE 550
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1020405, 1022601, 1026505, 1025202, 1023701, 1023801, and 1017702.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- GA, OR, TX, CO, KY, MT, MA, AL, CA, FL & TN.
  • 제품 설명
    ***REF #250***TAPSCOPE 550F. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series female connector thermistor. LOT xxxxxxx 400095-0250-C 100902. www.cardiocommand.com. || ***REF #250-0010***TAPSCOPE 550F CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400156-B 091101. || ***REF #250-0025***TAPSCOPE 550F Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistor. FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: CARDIOCOMMAND, INC.Tampa, FL USA 33607. (800) 231-6370(813) 289-5555. www.cardiocommand.com. 400216-A 100902.
  • Manufacturer
    Cardiocommand Inc.

Manufacturer

Cardiocommand Inc.
  • 제조사 주소
    Cardiocommand Inc., 4920 W Cypress St, Suite 110, Tampa FL 33607-3837
  • 제조사 모회사 (2017)
    Cardiocommand Inc.
  • Source
    USFDA