Recall database

Research Laser recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–1 of 1 recalls

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…

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).

Research Laser
Radiation Control for Health and Safety Act

Ithera Medical GmbhFeb 19, 2025