CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report
The MSOT Acuity Echo is a Class 4 medical laser device recalled
Ithera Medical is recalling The MSOT Acuity Echo is a Class 4 medical laser device, distributed nationwide in the US. The recall was initiated on 8 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1100-2025
- FDA event ID
- 96234
- Recalling firm
- Ithera Medical, Munich
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jan 2025
- FDA classified
- 7 Feb 2025
- Reported
- 19 Feb 2025
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 8 Jan 2025 | Recall initiated by company | |
| 7 Feb 2025 | Classified by FDA | +30 days |
| 19 Feb 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.
Questions about this recall
Why was it 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).
Which lots are affected?
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
Where was it sold?
Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |