Reported Oct 8, 2025 · Ongoing

Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type:…

MedicalCommunications GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MedicalCommunications GmbH · Max-Jarecki-Str. 8 · Heidelberg, N/A · N/A

Is this the product you have?

  • Ashvins variant HEYEX 2 / HEYEX PACS
  • Software VersionVersion 2.6.0 (Build 2088) to 2.6.8 (Build 2220)
  • Device TypeSoftware (Medical Image Management, Picture Archiving and Communication System)
Lot codes and dates
  • Model NameAshvins variant HEYEX 2 / HEYEX PACS
  • UDI-DI4260648620046
  • Software Version2.6.0 (Build 2088) to 2.6.8 (Build 2220)
Amount recalled
474 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.