Events

Recall of DatexOhmeda Aestiva/5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datex-Ohmeda Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28936
  • Event Risk Class
    Class 2
  • Event Number
    Z-0967-04
  • Event Initiated Date
    2004-04-16
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32837
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Apparatus, Gas-Scavenging - Product Code CBN
  • Reason
    Increased circuit pressure as a result of a misassembled aestiva/5 active gas scavenging system.
  • Action
    Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.

Device

DatexOhmeda Aestiva/5
  • 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
    Anesthesiology Devices
  • 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
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc
  • Manufacturer Address
    Datex-Ohmeda Inc, One Ohmeda Dr. Box 7550, Madison WI 53707
  • Source
    USFDA