| Class 2 Device Recall Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science). | |
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 | K003576 K082173 K864013 K990866 |
Product Classification |
stress treadmill - Product Code IOL
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IOL 510(K)s with Product Code = IOL
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