Recall Z-0288-2025 ยท QQH Powered Insertion System For A Cochlear Implant Electrode Array
Iotamotion Inc
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.
| Date | Nov 1, 2024 (initiated Sep 12, 2024) |
| Status | Completed |
| Reason | Incorrect GTIN number. |
| Root cause | Process control |
| Action | The firm did not issue any communication. They distributed the devices and saw through their ERP system that the devices had been used. The remainder of the devices were in the possession of the firm's VP, therefore, not viewed as "distributed." |
| Quantity | 5 devices |
| Distribution | Distribution was made to Iowa. There was no government/military/foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.