MedicalCommunications GmbH: Device Recall

Recall #Z-2673-2025 · 09/09/2025

Class II: Risk

Recall Details

Recall Number
Z-2673-2025
Classification
Class II
Product Type
Device
Recalling Firm
MedicalCommunications GmbH
Status
Ongoing
Date Initiated
09/09/2025
Location
Heidelberg, N/A, Germany
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
474 units

Reason for Recall

Potential that the measured value may be smaller than the actual area.

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)

Distribution Pattern

US Nationwide distribution.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.