Recall Z-1100-2025— Ithera Medical Gmbh
Class II · Ongoing
Class II FDA medical device recall by Ithera Medical Gmbh, initiated 2025-01-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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)..
- Recalling firm
- Ithera Medical Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-08
- Firm location
- Munich, Germany
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.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.