Device recall
Z-0288-2025: iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended…
FDA device recall · Class III · Iotamotion Inc
Key facts
| Recall number (Z-number) | Z-0288-2025 |
|---|---|
| Recall event | 95462 |
| Product | iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. |
| Product code | QQH |
| Recalling firm | Iotamotion Inc |
| Recall class | Class III |
| Status | Completed |
| FEI number | 3030411493 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database