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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 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
Recalling Firm/
Manufacturer
Accelerated Care Plus Corporation
4850 Joule St Ste A1
Reno NV 89502-4150
775-685-4000
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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