Events

Recall of Device Recall Terumo APS 1

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
    36398
  • Event Risk Class
    Class 3
  • Event Number
    Z-0312-2007
  • Event Initiated Date
    2004-05-01
  • Event Date Posted
    2006-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48593
  • 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
    cardiovascular perfusion system - Product Code DTQ
  • Reason
    The battery status light on the front panel may not accurately reflect the actual status of the battery. the battery may contain more charge than indicated.
  • Action
    U.S. consignees were visited and new software installed between May 2004 and November 2005. Currently, approximately 50% of exported units have been upgraded.

Device

Device Recall Terumo APS 1
  • Model / Serial
    Serial numbers 0006 through 0066.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.
  • Product Description
    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
  • 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