FDAHealthSeptember 9, 2025
MedicalCommunications GmbH — 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 Archi
⚠️ Potential that the measured value may be smaller than the actual area.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 9, 2025
US Nationwide distribution.
What's affected?
- 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)
- Lot code
- Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
Additional details
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 474 units.
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