Device Recall AXIOM Sensis

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.
  • 제품 설명
    AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 7 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Software Version VD10B
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : IN, MI, IA
  • 제품 설명
    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped two medical facilities in MA and MI and two units were used as demonstration units by the recalling firm.
  • 제품 설명
    Axiom Sensis. Programmable Diagnostic Computer
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers 1002, 1034, 1100-1253, 1300-1504
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped to 43 medical facilities nationwide and one government account in KY.
  • 제품 설명
    AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 1155, 6002, 6006-6014, 6016, 6018-6021, 6023-6025, 6027-6053, and 6100-6125. Model number 66 34 641 involves the following serial numbers: 4001-4008 and 4050-4056. Model number 66 34 658 involves the following serial numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055. Model number 66 48 161 involves the following serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.
  • 제품 설명
    AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 2001-2011, 2013-2023, 2025-2026, 2028, 2031-2067, 2069-2090, 2092-2132, 2134-2143, 2145-2148, 2150-2158, 2160-2260, 2262, and 2265-2266
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.
  • 제품 설명
    AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
  • Manufacturer
하나 더 2 건 더