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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 Initiated by Firm June 12, 2013
Date Posting Updated July 31, 2013
Recall Status1 Terminated 3 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, A000-533-06-12494099, A000-533-06-12494100, A000-533-06-12503014, A000-533-06-12504044, A000-533-06-12504045, A000-533-06-12504046, A000-533-06-12504047, A000-533-06-12504048, A000-533-06-12504049, A000-533-06-12504050, A000-533-06-12504060, A000-533-06-12504062, A000-533-06-12504063, A000-533-06-12504064, A000-533-06-12504065, A000-533-06-12504066, A000-533-06-12504067, A000-533-06-12504068, A000-533-06-12504091, A000-533-06-12504094, A000-533-06-12504100, A000-533-06-12504103, A000-533-06-12504105, A000-533-06-12504106, A000-533-06-12504108, A000-533-06-12504109, A000-533-06-12504110, A000-533-06-12504111, A000-533-06-12504112, A000-533-06-13022066, A000-533-06-13022067, A000-533-06-13022068, A000-533-06-13022069, A000-533-06-13022072, A000-533-06-13022074, A000-533-06-13022075, A000-533-06-13022076, A000-533-06-13022077, A000-533-06-13022078, A000-533-06-13022079, A000-533-06-13022080, A000-533-06-13022081, A000-533-06-13022082, A000-533-06-13022084, A000-533-06-13022085, A000-533-06-13035001, A000-533-06-13035002, A000-533-06-13035003, A000-533-06-13035004, A000-533-06-13035005, A000-533-06-13035006, A000-533-06-13035007, A000-533-06-13035008, A000-533-06-13035009, A000-533-06-13035011, A000-533-06-13035019, A000-533-06-13035020, A000-533-06-13035021, A000-533-06-13035022, A000-533-06-13035023, A000-533-06-13035024, A000-533-06-13035025, A000-533-06-13035026, A000-533-06-13035027, A000-533-06-13035028, A000-533-06-13035029, A000-533-06-13035030, A000-533-06-13035033, A000-533-06-13035034, A000-533-06-13035035, A000-533-06-13035036, A000-533-06-13035039, A000-533-06-13035040, A000-533-06-13035041, A000-533-06-13035042, A000-533-06-13035043, A000-533-06-13035044, A000-533-06-13035045, A000-533-06-13035046, A000-533-06-13035047, A000-533-06-13035048, A000-533-06-13035049, A000-533-06-13035051, A000-533-06-13035052, A000-533-06-13035053, A000-533-06-13035054, A000-533-06-13035055, A000-533-06-13035056, A000-533-06-13035058, A000-533-06-13035059, A000-533-06-13035060, A000-533-06-13035062, A000-533-06-13035063, A000-533-06-13035064, A000-533-06-13035065, A000-533-06-13035066, A000-533-06-13035067, A000-533-06-13035068, A000-533-06-13035070, A000-533-06-13035072, A000-533-06-13035073, A000-533-06-13035074, A000-533-06-13035122, A000-533-06-13035123, A000-533-06-13035125, A000-533-06-13035127, A000-533-06-13035128, A000-533-06-13035129, A000-533-06-13035130, A000-533-06-13035131, A000-533-06-13035132, A000-533-06-13035133, A000-533-06-13035134, A000-533-06-13035136, A000-533-06-13035137, A000-533-06-13035138, A000-533-06-13035139, A000-533-06-13035140, A000-533-06-13035141, A000-533-06-13035142, A000-533-06-13035144, A000-533-06-13035145, A000-533-06-13035146, A000-533-06-13035147, A000-533-06-13035148, TT006331046, TT007142002, TT007142004, TT007142081, TT007142090, TT007142091, TT007142093, TT007162097, TT007192023, TT007192035, TT007222001, TT007222098, TT007222100, TT007301006, TT007301009, TT007301010, TT007301019, TT007301021, TT007301028, TT007301031, TT007374042, TT007374043, TT007374048, TT007374070, TT007374080, TT007374081, TT007374085, TT007374090, TT007501002, TT007501009, TT007501087, TT007501092, TT007512079, TT007512081, TT007512089, TT007512090, TT007512099, TT008035017, TT008055038, TT008055042, TT008055043, TT008055046, TT008055053, TT008055060, TT008055063, TT008055069, TT008055074, TT008055075, TT008055078, TT008055079, TT008081006, TT008081007, TT008081008, TT008081082, TT008101006, TT008101010, TT008101100, TT008105006, TT008105008, TT008105014, TT008112063, TT008112067, TT008112068, TT008112069, TT008112080, TT008114091, TT008114093, TT008114096, TT008121074, TT008122097, TT008153003, TT008153008, TT008153010, TT008153024, TT008153027, TT008202012, TT008202013, TT008202015, TT008202020, TT008202026, TT008202027, TT008202030, TT008202042, TT008202046, TT008202053, TT008202060, TT008252039, TT008252050, TT008252052, TT008252057, TT008291015, TT008291017, TT008291021, TT008291023, TT008291025, TT0
Recalling Firm/
Accelerated Care Plus Corporation
4850 Joule St Ste A1
Reno NV 89502-4150
For Additional Information Contact Patrick Parker
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.