Ashvins HEYEX 2 (MedicalCommunications) – Measurement Inaccuracy (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany is recalling Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2 due to Potential that the measured value may be smaller than the actual area.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential that the measured value may be smaller than the actual area.
Recommended Action
Per FDA guidance
Ashvins notified consignees on about 09/09/2025 via emailed letter. Consignees were instructed to cease using the freeform measurement function in the MMV until the software update has been performed, which is now available. Consignees were instructed to perform the update as soon as possible, complete the digital Field Safety Notice Acknowledgement and Receipt Form, and maintain a copy of the letter and the user manual with the device until the software update is complete.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026