iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion… recallZ-0288-2025 · Iotamotion Inc · initiated Sep 12, 2024
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Iotamotion Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect GTIN number.
FDA root cause category: Process control
What the company is doing
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."
Recall details
- Recall number
- Z-0288-2025
- Status
- Completed
- Initiated by the company
- Sep 12, 2024
- Posted by the FDA
- Nov 1, 2024
- Recalling firm
- Iotamotion Inc
- Quantity
- 5 devices
- Product code
- QQH
- Distribution
- Distribution was made to Iowa. There was no government/military/foreign distribution.
Product description
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.
Code information (models, lots, serial numbers)
Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- iotaSOFT Insertion System IM-00Iotamotion, Inc. · Powered Insertion System For A Cochlear Implant Electrode Array1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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