Iotamotion Inc recalls iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochl…

Recall date

September 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0288-2025

FDA classification

Class III

Brand / firm

Iotamotion Inc

Sold / distributed

Distribution was made to Iowa. There was no government/military/foreign distribution.

Why it was recalled

Incorrect GTIN number.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.