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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard involves inadequate safety instructions for a Class 4 medical laser device with an incorrect critical safety parameter (NOHD). This represents a significant risk of eye injury, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
The MSOT Acuity Echo is a Class 4 medical laser device manufactured by Ithera Medical GmbH intended for imaging soft tissue and blood vessels using combined optoacoustic (photoacoustic) and ultrasound technology.
The device lacks adequate instructions for safe operation. Previous versions of the user manual contained an incorrect value for Nominal Ocular Hazard Distance (NOHD), a critical safety parameter that establishes safe operating distances to prevent eye injury.
The recall affects 23 units worldwide: 6 units in the United States and 17 units distributed to Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and the United Kingdom.
The recalled product
- 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.
- Manufacturer
- Ithera Medical Gmbh
Distribution
Distributed nationwide across the United States.
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