FDA Recall
Terminated
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
Recall: Z-1837-2013
·
Initiated June 12, 2013
Recall
- Recall Number
- Z-1837-2013
- Event Number
- 65498
- Firm
- Accelerated Care Plus Corporation
- FEI Number
- 1000119345
- Product Code
- BXB
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- June 12, 2013
- Posted
- July 31, 2013
- Terminated
- October 23, 2013
- Address
- 4850 Joule St, Ste A1, Reno, NV, 89502-4150
Description
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
Reason
An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
Action
Letters were issued on June 12, 2013 that included a memory stick with self loading software so consumers can update the device. Letters were sent by trackable method. Customers with questions or concerns should call Customer Support at 800-350-1100.
Distribution
Nationwide Distribution.
Quantity
1001 units