FDAJanuary 8, 2025device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Ongoing
Brands named
ithera medicalithera
UPCs
04262380070004
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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