Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science). see related information
Date Initiated by Firm March 30, 2009
Date Posted June 04, 2010
Recall Status1 Terminated 3 on January 10, 2012
Recall Number Z-1757-2010
Recall Event ID 51812
510(K)Number K990866  K864013  K003576  K082173  
Product Classification stress treadmill - Product Code IOL
Product Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).
Code Information 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
Recalling Firm/
Manufacturer		 Cardiac Science Corporation
3303 Monte Villa Pkwy
Bothell WA 98021-8969
For Additional Information Contact Michael Matysik
425-402-2206
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 28 treadmills
Distribution Distributed domestically (including Puerto Rico) to 20 end-user accounts and 2 distributor accounts; Distributed internationally to: Canada, Mexico, Portugal, and Saudi Arabia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IOL and Original Applicant = CARDIAC SCIENCE CORPORATION
510(K)s with Product Code = IOL and Original Applicant = QUINTON, INC.
-
-