Events

Recall of Device Recall Terumo APS1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

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
    44848
  • Event Risk Class
    Class 2
  • Event Number
    Z-1224-2009
  • Event Initiated Date
    2009-01-12
  • Event Date Posted
    2009-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64430
  • 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
    Cardiopulmonary Bypass Heart-Lung Machine Console - Product Code DTQ
  • Reason
    The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use.
  • Action
    Consignees were notified via an Urgent Medical Device Correction: Safety Advisory letter dated 1/12/09 advised of the reason for the correction, potential problems, and provided clinical information should the problem(s) arise. Customers are to review the notice, assure that all users are aware of the notice, and confirm receipt of the communication by completing the attached Customer Response Form and faxing it to the number indicated on the form. Questions or concerns should be directed to Terumo CVS Customer Service at 1-800-521-2818.

Device

Device Recall Terumo APS1
  • Model / Serial
    Serial numbers 0020 through 0980.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates, and Viet Nam.
  • Product Description
    Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100. || The Central Control Monitor (CCM) provides a centralized display of system information and on-screen control of all system devices. The CCM combines an embedded computer, a touchscreen, and a graphical user interface.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA