Devices

Device Recall Siemens syngo(R) Lab Data Manager

  • Modèle / numéro de série
    Version VA11B and all previously released versions.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.
  • Description du dispositif
    Siemens syngo(R) Lab Data Manager. || The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event

Fabricant

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA

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Device Recall Siemens syngo(R) Lab Data Manager Version VA11B and VA12A
  • Modèle / numéro de série
    Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) and internationally to Canada.
  • Description du dispositif
    syngo(R) Lab Data Manager - Version VA11B and VA12A Systems || Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.