Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version Recalled by MedicalCommunications GmbH Due to Potential that the measured value may be smaller...

Date: September 9, 2025
Company: MedicalCommunications GmbH
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MedicalCommunications GmbH directly.

Affected Products

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)

Quantity: 474 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MedicalCommunications GmbH

MedicalCommunications GmbH has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report