MSOT Acuity Echo (Ithera) – Safety Instruction (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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).

Recommended Action

Per FDA guidance

The firm sent an "Urgent Field Safety Notice" letter dated 12/19/2024 to its consignees. FSN 3746 has been distributed to all customers to correct a wrong value in the user manual for the NOHD. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: Take note of amendment/reinforcement of Instructions For Use (IFU) 1. Confirm the receipt of this FSN 2. Forward this information and the updated IFU to the person responsible for laser safety at your location (such as Laser Safety Officer) 3. The person responsible for laser safety at your location performs a new assessment of the laser safety consideration and to identify any additionally required work safety related measures 4. Training of all users of the MSOT Acuity Echo device on any additionally required work safety related measures, if applicable. The new calculation of the NOHD resulting in a higher value due to the use of a different calculation method. The user manual has been updated accordingly, and users have been informed. iThera will provide an updated user manual (IM_2.03_EN_III) with the corrected value for NOHD. If you have any questions, call 203-997-5110 US, +49-80-700749; EXT21 OUS or email: josef.konardl@ithera-medical.com.