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.

Class I - Dangerous

🏥 Medical Devices Recalled: January 8, 2025 Ithera Medical Gmbh Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Model numbers MSOT Acuity Echo (Research System) MSOT Acuity Echo CE MSOT Acuity Echo CE2 UDI's: (01)04262380070004 (01)04262380070004(21)22102 (01)04262380070004(21)22203 (01)04262380070004(21)21901 (01)04262380070004(21)22101 (01)04262380070004(21)22104 (01)04262380070004(21)22105 (01)04262380070004(21)22106 (01)04262380070004(21)22107 (01)04262380070004(21)22201 (01)04262380070004(21)22202 (01)04262380070004(21)22204 (01)04262380070004(21)22205 (01)04262380070004(21)22206 (01)04262380070004(21)22301 (01)04262380070004(21)22401
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Ithera Medical Gmbh
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).
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full 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.

Product Codes/Lot Numbers:

Model numbers MSOT Acuity Echo (Research System) MSOT Acuity Echo CE MSOT Acuity Echo CE2 UDI's: (01)04262380070004 (01)04262380070004(21)22102 (01)04262380070004(21)22203 (01)04262380070004(21)21901 (01)04262380070004(21)22101 (01)04262380070004(21)22104 (01)04262380070004(21)22105 (01)04262380070004(21)22106 (01)04262380070004(21)22107 (01)04262380070004(21)22201 (01)04262380070004(21)22202 (01)04262380070004(21)22204 (01)04262380070004(21)22205 (01)04262380070004(21)22206 (01)04262380070004(21)22301 (01)04262380070004(21)22401

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1100-2025