Devices

Device Recall Dimension Vista System

  • 모델명 / 제조번호(시리얼번호)
    Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments within the serial number range of B01060900055 through B01090100414R0, excluding B01081100388R0, B01081100389R0, B01081200396R0, B01081200402R0, B01081200403R0, B01081200404R0, B01081200406R0, B01081200408R0, B01081200410R0, B01081200411R0, B01090100412R0, B01090100413R0.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Portugal, Slovenia, Spain, and Switzerland.
  • 제품 설명
    Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event

제조사

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

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Device Recall Dimension Vista System BUN Flex Reagent Cartridge
Device Recall Dimension Vista System CHEM 1 CAL, Catalog Number KC110
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 9DM001
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia.
  • 제품 설명
    Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 || The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), || Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.