# FDA recall Z-1100-2025

> **Ithera Medical Gmbh** · Class II · device recall initiated 2025-01-08.

## 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).

## Distribution

Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.

## Key facts

- **Recall number:** Z-1100-2025
- **Recalling firm:** Ithera Medical Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-08
- **Report date:** 2025-02-19

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Munich, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2025

## Citation

> AI Analytics. FDA recall Z-1100-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1100-2025. Source: US FDA. Licensed CC0.

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