FDA Medical Device Recalls (openFDA)
Cardiac Science Corporation: Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).
- Recall number
- Z-1757-2010
- Recalling firm
- Cardiac Science Corporation
- Product
- Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).
- Status
- Terminated
- Initiated
- 2009-03-30
- Posted
- 2010-06-04
- Terminated
- 2012-01-10
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K003576","K082173","K864013","K990866"]
- PMA numbers
- not on file
- Product code
- IOL
- Firm FEI
- 2112020
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28