Recall Z-1757-2010
Cardiac Science Corporation · initiated March 30, 2009
Product
Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).
Codes / lots: 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
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: Other
Action taken
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.
Details
- Recall number
- Z-1757-2010
- Initiated
- March 30, 2009
- Posted by FDA
- June 4, 2010
- Terminated
- January 10, 2012
- Product code
- IOL – Treadmill, Powered
- Quantity
- 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.
- Recalling firm
- Cardiac Science Corporation, Bothell, WA