Device 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)
Z-2673-2025
Product summary
- Event
- Event 97509
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 474 units
- Official record key
device-enforcement:Z-2673-2025
Official wording
Reason: Potential that the measured value may be smaller than the actual area.
Code information: 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 pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Potential that the measured value may be smaller than the actual area.