Ashvins variant HEYEX 2 / HEYEX PACS — Class II medical device recall Z-2673-2025
Ongoing recall by MedicalCommunications GmbH, reported 2025-10-08, distributed nationwide. Potential that the measured value may be smaller than the actual area.
| Recall number | Z-2673-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MedicalCommunications GmbH, Heidelberg, N/A, Germany |
| Recall initiated | 2025-09-09 |
| Classified | 2025-09-30 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 474 units |
| UPC / GTIN / UDI-DI | 04260648620046 |
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)
Reason for recall
Potential that the measured value may be smaller than the actual area.
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-2673-2025. 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.