Recall Z-1757-2010 ยท IOL Treadmill, Powered
Cardiac Science Corporation
Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).
| Date | Jun 4, 2010 (initiated Mar 30, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003576 | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 Quinton, Inc., Jan 25, 2001 |
| K082173 | Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S Cardiac Science Corporation, Aug 26, 2008 |
| K864013 | MODEL Q55XT POWERED TREADMILL Quinton, Inc., Nov 14, 1986 |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL Quinton, Inc., Apr 29, 1999 |