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RecallWatchMedical Device Safety
Class IIOngoingZ-1100-2025

Ithera Medical Gmbh recalls The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile ass…

Ithera Medical GmbhMunich, GermanyReported Feb 19, 2025 · 1 year ago
Legal News Analyst ·

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).

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    Model numbers

What the firm is doing

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.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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