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Treadmill models TM55, TM65, and CR60 (brand names include… recallZ-1757-2010 · Cardiac Science Corporation · initiated Mar 30, 2009

Terminated All recalls posted in June 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cardiac Science Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1757-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 30, 2009
Posted by the FDA
Jun 4, 2010
Recalling firm
Cardiac Science Corporation
Quantity
28 treadmills
Product code
IOL
FDA submissions
K003576, K082173, K864013, K990866
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).

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

17 devices cleared under K003576, K082173, K864013, K990866 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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