PlainRecalls
FDA Devices Moderate Class II Ongoing

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)

Reported: October 8, 2025 Initiated: September 9, 2025 #Z-2673-2025

Product Description

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.

Details

Units Affected
474 units
Distribution
US Nationwide distribution.
Location
Heidelberg, N/A

Frequently Asked Questions

What product was recalled?
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). Recalled by MedicalCommunications GmbH. Units affected: 474 units.
Why was this product recalled?
Potential that the measured value may be smaller than the actual area.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 8, 2025. Severity: Moderate. Recall number: Z-2673-2025.