FDA Device recall Z-2673-2025
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220)
- FDA Device
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220) by Medicalcommunications, citing potential that the measured value may be smaller than the actual area.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2673-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-09 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medicalcommunications |
| Distribution | US |
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
Potential that the measured value may be smaller than the actual area.
Identifiers
| code_info | Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2673-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.