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U.S. Department of Health and Human Services

Class 2 Device Recall Omnicycle Elite

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 Class 2 Device Recall Omnicycle Elite see related information
Date Posted July 31, 2013
Recall Status1 Terminated on October 23, 2013
Recall Number Z-1837-2013
Recall Event ID 65498
Product Classification Exerciser, powered - Product Code BXB
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.
Code Information 6-12494097
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TT0
Recalling Firm/
Manufacturer
Accelerated Care Plus Corporation
4850 Joule St Ste A1
Reno NV 89502-4150
For Additional Information Contact Patrick Parker
775-685-4000
Manufacturer 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.
FDA Determined
Cause 2
Software design
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.
Quantity in Commerce 1001 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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