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

FDA device recall Z-1757-2010 · posted 2010-06-04 · Terminated

Recall details

Recalling firm

Cardiac Science Corporation

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

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.

Root cause

Other

Status

Terminated

Product code

IOL

Quantity affected

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.

Date initiated

2009-03-30

Date posted

2010-06-04

Date terminated

2012-01-10

Location

Bothell, WA

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