Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The MSOT Acuity Echo is a Class 4 medical laser Recalled by Ithera Medical Gmbh Due to The MSOT Acuity Echo does not include an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ithera Medical Gmbh directly.
Affected Products
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.
Quantity: 23 units (6 units US)
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ithera Medical Gmbh
Ithera Medical Gmbh has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report