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)
This recall is currently active, issued September 30, 2025. It was issued by Medicalcommunications Gmbh Max-Jarecki-Str. 8 Heidelberg Germany.
- Recall Initiated
- September 9, 2025
- Posted
- September 30, 2025
- Recall Number
- Z-2673-2025
- Quantity
- 474 units
- Official Source
- View on FDA website ↗
Reason for Recall
Potential that the measured value may be smaller than the actual area.
Distribution
US Nationwide distribution.
Lot / Code Info
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
Root Cause
Software design
Action Taken
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.