HIGH

MedicalCommunications GmbH Recalls HEYEX PACS Software Due to Measurement Errors

MedicalCommunications GmbH recalled 474 units of HEYEX PACS software on September 9, 2025. The software may inaccurately report measured values, posing risks to patient care. Users should stop using the software immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
September 9, 2025
Hazard Level
HIGH
Brand
MedicalCommunications GmbH
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact MedicalCommunications GmbH or your healthcare provider for instructions. Notification method: E-Mail

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Product Details

The recall involves the Ashvins variant HEYEX 2 / HEYEX PACS software, with versions ranging from 2.6.0 (Build 2088) to 2.6.8 (Build 2220). The software was distributed nationwide in the United States.

The Hazard

The software may report measured values that are smaller than the actual area. This could lead to misdiagnosis or incorrect treatment decisions, posing serious risks to patient safety.

Reported Incidents

As of the recall date, there have been no reported injuries or incidents associated with the software malfunction. However, the potential for harm remains high.

What to Do

Patients and healthcare providers must stop using the HEYEX PACS software immediately. Follow the manufacturer’s recall instructions by contacting MedicalCommunications GmbH or your healthcare provider.

Contact Information

For further assistance, reach MedicalCommunications GmbH via email as provided in the recall notification.

Key Facts

  • Device type: Medical Image Management Software
  • Recall quantity: 474 units
  • Recall classification: Class II
  • Potential measurement error poses high risk
  • Stop using the device immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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