Events

Recall of Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764.

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

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
    30352
  • Event Risk Class
    Class 2
  • Event Number
    Z-0209-05
  • Event Initiated Date
    2003-08-12
  • Event Date Posted
    2004-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35720
  • 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
    Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
  • Reason
    The central control monitor screen may go blank during use because of a bad wiring connection in the wiring harness or a low voltage setting on the potentiometer.
  • Action
    Service representatives were sent a service bulletin dated 8/12/03 instructing them to correct units in the field bearing serial numbers between 20 and 109.

Device

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source ...
  • Model / Serial
    All units bearing serial numbers 20 through 109.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Japan, Korea, Singapore and United Kingdom.
  • Product Description
    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA