FDA recall Z-2673-2025

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2025-09-09

Report date

2025-10-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Heidelberg, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2673-2025