FDAFDA · Food and drugs·Recall number Z-1837-2013

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.

Published August 7, 2013 · Recall initiated: June 12, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Accelerated Care Plus Corporation
Distributor: Nationwide Distribution.
Lot: Model number A000-533: Serial numbers: 1034-000-00-09033104 1034-000-00-09033107 1034-000-00-09033108 1034-000-00-09033119 1034-000-00-09033120 1034-000-00-09033121 1034-000-00-09033122 1034-000-00-09033132 1034-000-01-09073002 1034-000-01-09073005 1034-000-01-09073018 1034-000-01-09073021 1034-000-01-09073030 1034-000-01-09073123 1034-000-01-09073129 1034-000-01-09073130 1034-000-01-09073134 1034-000-01-09073136 1034-000-01-09073142 1034-000-01-09073146 1034-000-01-09073147 1034-000-01-09090034 1034-000-01-09101119 1034-000-01-09101126 1034-000-01-09101127 1034-000-01-09102107 1034-000-01-09104132 1034-000-01-09105032 1034-000-01-09105039 1034-000-01-09152114 1034-000-01-09152117 1034-000-01-09152120 1034-000-01-09152131 1034-000-01-09162027 1034-000-01-09162034 1034-000-01-09163094 1034-000-01-09163101 1034-000-01-09164098 1034-000-01-09164101 1034-000-01-09164114 1034-000-01-09171128 1034-000-01-09172011 1034-000-01-09172020 1034-000-01-09172021 1034-000-01-09172026 1034-000-01-09172028 1034-000-01-09172035 1034-000-01-09172041 1034-000-01-09172042 1034-000-01-09172046 1034-000-01-09172049 1034-000-01-09172053 1034-000-01-09172060 1034-000-01-09172064 1034-000-01-09172066 1034-000-01-09172070 1034-000-01-09172074 1034-000-01-09172083 1034-000-01-09201007 1034-000-01-09201105 1034-000-01-09201113 1034-000-01-09201118 1034-000-01-09201124 1034-000-01-09201125 1034-000-01-09201133 1034-000-01-09201135 1034-000-01-09201138 1034-000-01-09201139 1034-000-01-09261004 1034-000-01-09261006 1034-000-01-09261008 1034-000-01-09261009 1034-000-01-09261011 1034-000-01-09261017 1034-000-01-09261019 1034-000-01-09261033 1034-000-01-09261048 1034-000-01-09261060 1034-000-01-09261067 1034-000-01-09261077 1034-000-01-09261081 1034-000-01-09261090 1034-000-01-09261092 1034-000-01-09294043 1034-000-01-09294051 1034-000-01-09294052 1034-000-01-09294057 1034-000-01-09294059 1034-000-01-09294071 1034-000-01-09294072 1034-000-01-09294075 1034-000-01-09294078 1034-000-01-09294079 1034-000-01-09294087 1034-000-01-09294098 1034-000-01-09294099 1034-000-01-09294100 1034-000-01-09294101 1034-000-01-09313043 1034-000-01-09351002 1034-000-01-09351028 1034-000-01-09351035 1034-000-01-09351039 1034-000-01-09351149 1034-000-01-09355014 1034-000-01-09355015 1034-000-01-09355016 1034-000-01-09355017 1034-000-01-09363148 1034-000-01-09372065 1034-000-01-09372070 1034-000-01-09372080 1034-000-01-09402005 1034-000-01-09405073 1034-000-01-09405084 1034-000-01-09405088 1034-000-01-09411123 1034-000-01-09411128 1034-000-01-09411133 1034-000-01-09415083 1034-000-01-09415098 1034-000-01-09423019 1034-000-01-09423022 1034-000-01-09431090 1034-000-01-09431093 1034-000-01-09434017 1034-000-01-09473101 1034-000-01-09473107 1034-000-01-09474133 1034-000-01-09474134 1034-000-01-09475006 1034-000-01-09475024 1034-000-01-09475025 1034-000-01-09481033 1034-000-01-09502061 1034-000-01-09502067 1034-000-01-09503084 1034-000-01-09503096 1034-000-01-09504131 1034-000-01-09504134 1034-000-01-10026066 1034-000-01-10026068 1034-000-01-10026069 1034-000-01-10026070 1034-000-01-10026071 1034-000-01-10026074 1034-000-01-10032062 1034-000-01-10032065 1034-000-01-10032068 1034-000-01-10034025 1034-000-01-10034026 1034-000-01-10042037 A000-533-00-10043133 A000-533-00-10043135 A000-533-00-10043143 A000-533-00-10050064 A000-533-00-10050066 A000-533-00-10050069 A000-533-00-10050074 A000-533-00-10050076 A000-533-00-10050079 A000-533-00-10050082 A000-533-00-10050084 A000-533-00-10050085 A000-533-00-10050088 A000-533-00-10050091 A000-533-00-10050092 A000-533-00-10051032 A000-533-00-10051034 A000-533-00-10052065 A000-533-00-10052066 A000-533-00-10052072 A000-533-00-10054001 A000-533-00-10054002 A000-533-00-10054133 A000-533-00-10054136 A000-533-00-10054140 A000-533-00-10054143 A000-533-00-10054147 A000-533-00-10056058
Risk classification: Class II
Area (FDA): device
Country: United States

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