Omnicycle Elite Medical Exercise Equipment Recalled for Firmware Anomaly
Accelerated Care Plus is recalling 1,001 Omnicycle Elite units due to a firmware anomaly that may cause the equipment to operate at an incorrect speed in reverse mode.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical exercise equipment) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Accelerated Care Plus Corporation is recalling 1,001 units of the Omnicycle Elite, a powered exercise equipment intended for medical purposes. The product was manufactured by Medica Medizintechnik GmbH in Hochdorf, Germany, and distributed nationwide in the United States.
The recall is due to an anomaly in the firmware that may cause the Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode. The source text does not report any injuries or illnesses associated with this defect.
Consumers should stop using the affected equipment and contact Accelerated Care Plus Corporation for further instructions. The recall covers specific serial numbers listed in the official FDA notice Z-1837-2013.
The recalled product
- 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.
- Manufacturer
- Accelerated Care Plus Corporation
- Affected units
- 1,001
Distribution
Distributed nationwide across the United States.
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