FDA Medical Device Recalls (openFDA)
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 Archiving and Communication System)
- Recall number
- Z-2673-2025
- Recalling firm
- MedicalCommunications GmbH
- 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)
- Status
- Open, Classified
- Initiated
- 2025-09-09
- Posted
- 2025-09-30
- Terminated
- not on file
- Reason
- Potential that the measured value may be smaller than the actual area.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 474 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
- 510(k) numbers
- K200132
- PMA numbers
- not on file
- Product code
- NFJ
- Firm FEI
- 3003995303
- Firm city
- Heidelberg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28