Datex-Ohmeda Inc

6 devices in the database

  • Model / Serial
    The monitors in the serial number range FBWF00725 through FBWF03055 and FBWG00001 through FBWG02015 could be affected by the problem if they are mounted on the optional mounting stands for the product. The consignees notified of the field correction had purchased both the monitors and the stands.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The monitors were shipped to consignees located nationwide in the United States and to foreign consignees located worldwide.
  • Product Description
    Datex-Ohmeda Cardiocap/5 Patient Monitors
  • Model / Serial
    Serial numbers AMTG00208, AMTG00212, AMTG00213, AMTG00216, AMTG00219, AMTG00220, AMTG00222, AMTH00113, AMTH00121, and AMTH00124
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The affected units were distributed nationwide in the United States and worldwide.
  • Product Description
    Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.
  • Model / Serial
    Serial numbers AMVG01045, AMVG01047, AMVG01052, AMVG01062, AMVG01072 thru AMVG01083, AMVH00100 thru AMVH00109, AMVH00116, AMVH00125, AMVH00126, AMVH00129, AMVH00132, AMVH00133, AMVH00139, AMVH00141 thru AMVH00148, AMVH00151 thru AMVH00154, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00171 thru AMVH00186, AMVH00195 thru AMVH00198, AMVH00211, and AMVH00228 thru AMVH00230
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The affected units were distributed nationwide in the United States and worldwide.
  • Product Description
    Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.
  • Model / Serial
    Serial numbers AMRG02807, AMRG02889 thru AMRG02899, AMRG02930, AMRG02937 thru AMRG02942, AMRG02955, AMRG02958, AMRG02967, AMRG02968, AMRG02969, AMRG02979 thru AMRG03005, AMRG03012 thru AMRG03014, AMRG03017, AMRG03018, AMRG03030, AMRG03057 thru AMRG03062, AMRG03072, AMRG03077, AMRG03080, AMRG03081, AMRG03084, thru AMRG03088, AMRG03115, AMRG03155, AMRG03156, AMRG03174, AMRG03180 thru AMRG03185, AMRG03198, AMRG03199, AMRG03201, AMRG03208, AMRG03209, AMRG03212 thru AMRG03215, AMRG03222 thru AMRG03224, AMRG03261 thru AMRG03270, AMRG03298 thru AMRG03306, AMRG03331 thru AMRG03347, AMRG03351 thru AMRG03353, AMRH00124, thru AMRH00140, AMRH00143, AMRH00151, AMRH00152, AMRH00163, AMRH00169, AMRH00169, AMRH00170, AMRH00174 thru AMRH00181, AMRH00184, AMRH00185, AMRH00190 thru AMRH00202, AMRH00232 thru AMRH00237, AMRH00243, AMRH00244, AMRH00246, AMRH00247, AMRH00259, thru AMRH00276, AMRH00290 thru AMRH00307, AMRH00309, thru AMRH00311, AMRH00328, AMRH00329, AMRH00363 thru AMRH00368, AMRH00376, AMRH00382, thru AMRH00387, AMRH00396 thru AMRH00399, AMRH00399, AMRH00429, AMRH00430, AMRH00433, thru AMRH00439, AMRH00445 thru AMRH00464, AMRH00468, AMRH00469, AMRH00472 thru AMRH00474, AMRH00497 thru AMRH00502, AMRH00511 thru AMRH00513, AMRH00538 AMRH00543, AMRH00561 thru AMRH00571 thru AMRH00587, AMRH00589 thru AMRH00591, AMRH00594, AMRH00597 thru AMRH00603, AMRH00605 thru AMRH00626, AMRH00628 thru AMRH00636, AMRH00651, AMRH00652, AMRH00655 thru AMRH00657, AMRH00659 thruAMRH00661, AMRH00663 thru AMRH00669, AMRH00671, AMRH00672, AMRH00674 thru AMRH00676, AMRH00682, AMRH00684, and AMRH00704 thru AMRH00717
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The affected units were distributed nationwide in the United States and worldwide.
  • Product Description
    Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine
  • Model / Serial
    The affected units in the United States have serial numbers between 40013635 and 40162379.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide to hospitals in the Unites States.
  • Product Description
    Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units || (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.)
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9 manufacturers with a similar name

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  • Manufacturer Address
    Datex-Ohmeda Inc, 3030 Ohmeda Drive, PO Box 7550, zip 53707-7550, Madison WI 53718
  • Source
    USFDA
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