Ithera Medical Gmbh is recalling 23 units (including 6 in the U.S.) of the MSOT Acuity Echo, a Class 4 medical laser device used for imaging soft tissues and blood vessels. The recall was issued because previous versions of the user manuals contained the wrong value for the Nominal Ocular Hazard Distance (NOHD), which is the safe distance for eye safety. Using the device with incorrect safety distance instructions could lead to accidental eye exposure to hazardous laser radiation. No incidents or injuries have been reported to date.
Operating the laser based on incorrect safety distance instructions increases the risk of accidental eye exposure, which can cause permanent eye damage or vision loss for operators and bystanders.
The device is a Class 4 medical laser intended for imaging of soft-tissue and vasculature.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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