Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2014-10-08 | Z-0106-2015 | Class II | Terminated | The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .Distribution: Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland. | 13 kits (26 electrodes, 26 applicator wands, 26 leadwires). | clearance family |
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-04-07 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 0 |
| 2022-04-07 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 0 |
| 2019-06-27 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 12 |
| 2019-06-27 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 12 |
| 2017-09-05 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 5 |
| 2017-09-05 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 5 |
| 2014-06-20 | NAI | No action indicated | Ad-Tech Medical Instrument Corporation | 0 |
| 2014-06-20 | NAI | No action indicated | Ad-Tech Medical Instrument Corporation | 0 |
| 2013-11-14 | WL | Warning Letter | Ad-Tech Medical Instrument Corporation | — |
| 2013-11-14 | WL | Warning Letter | Ad-Tech Medical Instrument Corporation | — |
| 2013-06-05 | OAI | Official action indicated | Ad-Tech Medical Instrument Corporation | 7 |
| 2013-06-05 | OAI | Official action indicated | Ad-Tech Medical Instrument Corporation | 7 |
| 2012-11-26 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 5 |
| 2012-11-26 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 5 |
| 2012-04-12 | WL | Warning Letter | Ad-Tech Medical Instrument Corporation | — |
| 2012-04-12 | WL | Warning Letter | Ad-Tech Medical Instrument Corporation | — |
| 2012-01-11 | OAI | Official action indicated | Ad-Tech Medical Instrument Corporation | 0 |
| 2012-01-11 | OAI | Official action indicated | Ad-Tech Medical Instrument Corporation | 0 |
| 2011-02-24 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 9 |
| 2011-02-24 | VAI | Voluntary action indicated | Ad-Tech Medical Instrument Corporation | 9 |
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