Medical Device Recall: 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 c
Ithera Medical Gmbh · January 8, 2025
Reason for Recall
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).
Product Description
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.
Distribution
Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.
States Affected
NATIONWIDE
Quantity Affected
23 units (6 units US)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1100-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.