Recall Z-1837-2013— Accelerated Care Plus Corporation
Class II · Terminated
Class II FDA medical device recall by Accelerated Care Plus Corporation, initiated 2013-06-12, terminated 2013-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Accelerated Care Plus Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-12
- Terminated
- 2013-10-23
- Firm location
- Reno, NV, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.