Medical laser device recalled for inadequate safety operating instructions
Ithera Medical is recalling the MSOT Acuity Echo medical laser device worldwide due to inadequate instructions for safe operation. Previous user manuals contained an incorrect Nominal Ocular Hazard Distance value.
- 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.
- Category
- Medical Device
- Distribution
- Distributed nationwide