FDA Medical devices recall ·
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0… recall
- Recall number
- Z-2673-2025
- Date
- (initiated September 9, 2025)
- Company / brand
- MedicalCommunications GmbH
Max-Jarecki-Str. 8, Heidelberg, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 474 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
Potential that the measured value may be smaller than the actual area.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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).
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2673-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.