Ithera Medical Gmbh recalls The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered co…

Recall date

January 8, 2025

Source

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

Recall number

Z-1100-2025

FDA classification

Class II

Brand / firm

Ithera Medical Gmbh

Sold / distributed

Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.

Why it was recalled

The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.