Devices

Device Recall AXIOM Sensis

  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
  • Manufacturer
    Siemens Medical Solutions USA, Inc
  • 1 Event

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA

7 devices with a similar name

Learn more about the data here

Device Recall AXIOM Sensis Vibe Systems
  • Model / Serial
    Software Version VD10B
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : IN, MI, IA
  • Product Description
    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall Axiom Sensis
  • Model / Serial
    Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Axiom Sensis. Programmable Diagnostic Computer
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall Axiom Sensis Report Workstation
  • Model / Serial
    Serial Numbers 1002, 1034, 1100-1253, 1300-1504
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to 43 medical facilities nationwide and one government account in KY.
  • Product Description
    AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall AXIOM Sensis
  • Model / Serial
    Serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall AXIOM Sensis
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
  • Manufacturer
    Siemens Medical Solutions USA, Inc
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