Device Recall Empi STIMC RE Self Adhesive electrodes

  • 모델명 / 제조번호(시리얼번호)
    Lots 200300 and 201203
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including CA, IL, MA, MN, and SD.
  • 제품 설명
    Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand || A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Covidien LLC dba Uni-Patch, 1313 Grant Blvd W, Wabasha MN 55981-1058
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA