The Recall Desk
HighFDA (Devices)·Z-2673-2025·Announced 2025-10-08

Ophthalmic imaging software recalled over measured areas smaller than actual values

MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: an area measurement reported smaller than actual can misinform clinical assessment, and no injuries are reported.

Plain-English summary

The Ashvins variant of HEYEX 2 / HEYEX PACS, a medical image management and picture archiving and communication system, is being recalled for software versions 2.6.0 (Build 2088) through 2.6.8 (Build 2220).

There is a potential that the measured value may be smaller than the actual area.

The recall covers 474 units carrying UDI-DI 4260648620046, distributed nationwide in the United States. The FDA has classified the action as Class II.

Sites running the affected software versions should follow the manufacturer's instructions and treat area measurements from those versions with caution until the software is updated.

The recalled product

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)
Manufacturer
MedicalCommunications GmbH
Category
Medical Device — Imaging software
Hazard
  • software-defect
  • inaccurate-measurement
  • diagnostic-error

Distribution

Distributed nationwide across the United States.

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