ClearanceBrief
Recall Z-1837-2013 ยท BXB Exerciser, Powered

Accelerated Care Plus Corporation

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.

DateJul 31, 2013 (initiated Jun 12, 2013)
StatusTerminated
ReasonAn anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
Root causeSoftware design
ActionLetters 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.
Quantity1001 units
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.