Device Recall Siemens Healthcare

  • Model / Serial
    Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK.
  • Product Description
    Siemens RAPIDComm¿ Data Management System. || The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Drive, Norwood MA 02062
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

13 devices with a similar name

Learn more about the data here

  • Model / Serial
    Vista software version 3.4
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland & Baltics, France, Germany, Italy, Japan, South Korea, Malaysia, Netherlands, New Zealand, Norway, Portugal, Puerto Rico, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland and United Kingdom.
  • Product Description
    Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 || The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista(R) chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use.
  • Manufacturer
  • Model / Serial
    All lot codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
  • Product Description
    Siemens Healthcare BNP (8-type Natriuretic Peptide) || 500 Test kit 02816634 || 100 Test 02816138 || 10309045, 10309044 028 || Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure.
  • Manufacturer
  • Model / Serial
    All lot codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
  • Product Description
    Siemens Healthcare BR Assay for CA 27.29 || 250 Test Kits 03896216 || 50 Test Kit 02419937 || Ref Kit (US only) 10340081 || Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer.
  • Manufacturer
  • Model / Serial
    All lot codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
  • Product Description
    Siemens Healthcare ADVIA Centaur CA 19-9 || 250 Test 10491244 || 50 Test 10491379 || Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas.
  • Manufacturer
  • Model / Serial
    All lot codes
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
  • Product Description
    Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) || 50 Test 06489701 || The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Centaur XP systems
  • Manufacturer
8 more