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Bertec Vision Trainer System (BVT)

BERTEC CORPORATION · Model 95P-0014 · UDI-DI 00850017250093

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Bertec Vision Trainer System (BVT) is a device that objectively measures the performance of subject’s visuo-motor skills. It consists of a large touchscreen monitor, a force plate, and the BVT software. The subject interacts with the screen by touching and/or moving their center of pressure in response to a target stimulus, both dynamic and static.

Recalls

Date	Firm	Reason
2023-05-31	Trexo Robotics Holdings Inc.	Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.
2020-06-08	Hocoma AG	The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrol
2013-12-03	MedX Holdings, Inc.	Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
2012-05-05	Interactive Motion Technologies, Inc.	Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.