Events

Device Recall PercuNav MP008RB Button Probe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    57223
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0617-2011
  • 사례 시작날짜
    2010-11-10
  • 사례 출판 날짜
    2010-12-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95625
  • 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, x-ray, tomography, computed - Product Code JAK
  • 원인
    The protective cover over the tip of the mp008r-b button probe may fall off, causing the probe tip to damage the packaging and compromise the sterility of the probe.
  • 조치
    On 11/10/10, Philips issued URGENT - Medical Device Recall notification letters dated November 10, 2010 to their consignees. Consignees are advised to examine their inventory of MP008R-B Button Probes to confirm the probe tip cover is properly placed over the tip of the probe. They should discard any Button Probes that have been confirmed to have the protective probe tip cover removed from the Button Probe tip. Consignees are also reminded to follow the MP008R-B Button Probe and PercuNav Instructions for Use prior to using the device. Do not use the probe if the unit package is damaged, broken or soiled. The firm's representative will contact the consignees to confirm quantities and Lot Codes of MP008R-B Button Probes that the firm may have examined or discarded. The firm estimates replacement probes will be available in the first quarter of 2011. Consignees can contact Philips Customer Service at 800 722-9377 and reference the FCO 79500189.

Device

Device Recall PercuNav MP008RB Button Probe
  • 모델명 / 제조번호(시리얼번호)
    Lot codes and Expiry Date: I280903 (09-2012); C151005 (03-2013); E111003 (05-2013); and E251002 (05-2013).
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: in the states of FL, IL, MA, NE, NY, SC, and VA. There are no foreign consignees and US government consignees.
  • 제품 설명
    The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image Guided Intervention System. Some of the clinical applications of the Button Probe require sterility and others may not. However, it is possible that patient contamination could occur if a non-sterile Button Probe is used in clinical applications where aseptic technique is required. || The device's labeled in part: " TRAXTAL PERCUNAV...(1) Button Probe Right hand version, 25mm...Traxtal Inc...49 Spadina Avenue, Suite 310 Toronto, ON Canada M5V 2J1...Made In Canada...www.traxtal.com...STERILE...For use with Traxtal's PercuNav system only. Do not use if package is opened or damaged. Dispose of safely after single use to avoid risk of infection...Rx only...Use immediately after opening unit package. Store at room temperature".
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA