Reported Feb 19, 2025 · Ongoing
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered…
Ithera Medical GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ithera Medical Gmbh · Zielstattstr. 13 · Munich · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- 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
- Amount recalled
- 23 units (6 units US)
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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