Device Recall AXIOM Sensis

  • Modèle / numéro de série
    Serial numbers: 4001-4008 and 4050-4056.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Société-mère du fabricant (2017)
  • Source
    USFDA

7 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Software Version VD10B
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : IN, MI, IA
  • Description du dispositif
    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
  • Manufacturer
  • Modèle / numéro de série
    Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped two medical facilities in MA and MI and two units were used as demonstration units by the recalling firm.
  • Description du dispositif
    Axiom Sensis. Programmable Diagnostic Computer
  • Manufacturer
  • Modèle / numéro de série
    Serial Numbers 1002, 1034, 1100-1253, 1300-1504
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to 43 medical facilities nationwide and one government account in KY.
  • Description du dispositif
    AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
  • Manufacturer
  • Modèle / numéro de série
    Serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161
  • Manufacturer
  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
  • Manufacturer
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