Device recall
Z-2673-2025: Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build…
FDA device recall · Class II · MedicalCommunications GmbH
Key facts
| Recall number (Z-number) | Z-2673-2025 |
|---|---|
| Recall event | 97509 |
| Product | Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System) |
| Product code | NFJ |
| Recalling firm | MedicalCommunications GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200132 |
| FEI number | 3003995303 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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