FDA Device recall Z-1782-2018
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation trai…
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation trai… by Ondamed, citing 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 ha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1782-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-07 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ondamed |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | M011007 M011012 M011013 M011021 M011022 M011026 M011027 M011028 M030202 M030204 M030205 M030211 M030211b (D…M011007 M011012 M011013 M011021 M011022 M011026 M011027 M011028 M030202 M030204 M030205 M030211 M030211b (Dup) M030212 M030213 M030217 M030218 M030219 M030222 M030225 M030226 M030227 M030228 M030229 M030230 M030231 M030232 M030238 M030242 M030244 M030246 M030247 M030248 M030249 M040201 M040202 M040203 M040204 M040207 M040208 M040209 M040210 M040218a M040218b M040218c M040219 M040220 M040221 M040221a M040222 M040223 M040224 M040225 M040226 M040237 M040238 M040242 M040243 M040245 M040246 M040248 M040248a M040253 M040254 M040255 M040260 M050400 M050413 M050414 M050415 M050416 M050419 M050419a M050420 M050421 M050423 M050425 M050426 M050428 M050430 M050431 M050431 M050432a M050436 M050438 M050439 M050440 M050447 M050447a M050453 M050456 M050457 M050458 M051101 M051102 M051103 M051105 M051110 M051111 M051112 M051113 M051114 M051115 M051116a M051120 M051121 M051124 M051125 M051133 M05 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1782-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.