Ithera Medical recalls the MSOT Acuity Echo Class 4 medical laser device due to incorrect Nominal Ocular Hazard Distance values in previous user manuals, posing risks during medical imaging procedures.
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).
Ithera Medical is recalling the MSOT Acuity Echo Class 4 medical laser device because older user manuals contained incorrect values for the Nominal Ocular Hazard Distance (NOHD). This could lead to unsafe use during medical imaging procedures if the device is operated without proper understanding of the safety parameters.
The device's previous user manuals had incorrect Nominal Ocular Hazard Distance (NOHD) values, which are critical for determining safe operating distances to prevent eye damage. Using the device with outdated instructions could result in unsafe exposure to the laser light.
Healthcare professionals using the MSOT Acuity Echo for medical imaging are most at risk, particularly those who rely on the device without updated safety instructions.
The MSOT Acuity Echo (Research System) with model numbers including 'MSOT Acuity Echo CE', 'MSOT Acuity Echo CE2', and UDI codes starting with (01)04262380070004 are affected. This device was sold for medical imaging purposes.
Check if your device has the previous version of user manuals with incorrect Nominal Ocular Hazard Distance values.
Reach out to Ithera Medical to confirm if your device requires updated safety instructions.
The previous version of user manuals contained incorrect values for the Nominal Ocular Hazard Distance (NOHD), which could lead to unsafe use during medical imaging procedures.
The affected devices have model numbers including 'MSOT Acuity Echo CE', 'MSOT Acuity Echo CE2', and UDI codes starting with (01)04262380070004.
No, but you should review your user manuals and contact Ithera Medical to ensure you have updated safety instructions.
We’ve drafted a message you can send Ithera Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1100-2025 — Ithera Medical Ithera Medical Hello, I own a Ithera Medical that is covered by recall Z-1100-2025 from Ithera Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
