Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1757-2010

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

ZOLL Medical Corporation / initiated 2009-03-30 / Terminated / root cause: manufacturing process

Cardiac Science Corporation began a recall of Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science) on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1757-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ZOLL Medical Corporation
Product
Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).
Product code
IOL Treadmill, Powered
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
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and 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