Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
FDA Recall Z-1782-2018 · Posted None
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Recalling FirmOndamed Inc
Recall StatusTerminated
Product CodeHCC
Date Initiated2017-07-07
Date Terminated2020-04-24
Product Quantity585
Reason for Recall
The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2.
Firm Action
On July 7, 2017, the firm notified affected customers that the firm had made design changes to the Ondamed Biofeedback System. Customers were asked to contact the firm as soon as possible to make arrangements to return their devices for upgrade.
Customers may contact the firm at 1-845-534-0456, or by email at [email protected]. For further questions, please call (845) 496-6673.
Root Cause
No Marketing Application
Distribution Pattern
Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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