Ithera Medical Gmbh: Device Recall
Recall #Z-1100-2025 · 01/08/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1100-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Ithera Medical Gmbh
- Status
- Ongoing
- Date Initiated
- 01/08/2025
- Location
- Munich, Germany
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 23 units (6 units US)
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 Pattern
Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.