Device recall
Z-1100-2025: The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a…
FDA device recall · Class II · Ithera Medical Gmbh
Key facts
| Recall number (Z-number) | Z-1100-2025 |
|---|---|
| Recall event | 96234 |
| 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. |
| Product code | REK |
| Recalling firm | Ithera Medical Gmbh |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3011440527 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database