New Windsor, NY, United States
Ondamed Inc recalls
1 recall recorded since 2018, most recently on 7 July 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 July 2017
- Terminated
- 24 April 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1782-2018
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.