The MSOT Acuity Echo is a Class 4 medical laser device — Class II medical device recall Z-1100-2025
Ongoing recall by Ithera Medical Gmbh, reported 2025-02-19, distributed nationwide. The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous v
| Recall number | Z-1100-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Ithera Medical Gmbh, Munich, Germany |
| Recall initiated | 2025-01-08 |
| Classified | 2025-02-07 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, GB, IT, NL, PT |
| UPC / GTIN / UDI-DI | 04262380070004 |
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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1100-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.