Reported May 16, 2018 · Terminated
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated…
Ondamed Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ondamed Inc · 80 Waterview Ter · New Windsor, NY · 12553-5904
Is this the product you have?
- 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.
- Lot codes and dates
- (Dup)
M011007M011012M011013M011021M011022M011026M011027M011028M030202M030204M030205M030211M030211b
509 of 509 codes
M030212M030213M030217M030218M030219M030222M030225M030226M030227M030228M030229M030230M030231M030232M030238M030242M030244M030246M030247M030248M030249M040201M040202M040203M040204M040207M040208M040209M040210M040218aM040218bM040218cM040219M040220M040221M040221aM040222M040223M040224M040225M040226M040237M040238M040242M040243M040245M040246M040248M040248aM040253M040254M040255M040260M050400M050413M050414M050415M050416M050419M050419a
- Amount recalled
- 585
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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