Events

Recall of Device Recall Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiac Science 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
    51812
  • Event Risk Class
    Class 2
  • Event Number
    Z-1757-2010
  • Event Initiated Date
    2009-03-30
  • Event Date Posted
    2010-06-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81323
  • 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
    stress treadmill - Product Code IOL
  • Reason
    28 stress and rehab treadmills manufactured between september 2006 and january 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. if these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. because safety testing may not have allowed for complete evaluation of the el.
  • Action
    On April 3, 2009 the recalling firms notified consignees by certified letter to domestic customers and via FedEx to international customers with delivery confirmation signature required. Customers were advised to remove treadmill from service until it is tested by a Field Service Engineer. For customers with questions or those that have not already scheduled a service call with Cardiac Science Field Service Engineers, please contact the firm at 1.800.426.0337, option 1.

Device

Device Recall Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and C...
  • Model / Serial
    Lot/Serial Numbers: 11040077414 ,11040077801 ,11040077859 ,11040077861 ,11040077969 ,11040077977 ,11040077974 ,11040078366 ,11040078367 ,11040078375 ,11040078376 ,11040078379 ,11040078385 ,11040078384 ,11040078368 ,11040078395 ,11040078452 ,11040078891 ,11040079014 ,11040079161 ,11040079568 ,11040079567 ,11040079569 ,11040079671 ,11040079734 ,11040079939 ,11040079880 ,11040080124
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed domestically (including Puerto Rico) to 20 end-user accounts and 2 distributor accounts; Distributed internationally to: Canada, Mexico, Portugal, and Saudi Arabia.
  • Product Description
    Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Manufacturer Address
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Manufacturer Parent Company (2017)
    Cardiac Science Corporation
  • Source
    USFDA