Z-2673-2025Class II

Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220)...

Name: Z-2673-2025 Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220)...
Creator: MedicalCommunications GmbH
Published: 2025-09-09
License: https://open.fda.gov/license/

Medicalcommunications GmbH / initiated 2025-09-09 / Open, Classified / root cause: software

FDA source

MedicalCommunications GmbH began a recall of 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... on 2025-09-09. FDA classified it as Class II and gives the reason as "Potential that the measured value may be smaller than the actual area". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2673-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-09
Posted: 2025-09-30
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)
Product code: NFJ System, Image Management, Ophthalmic
Reason for recall: Potential that the measured value may be smaller than the actual area.
Root cause tag: software
FDA 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 in commerce: 474 units
Distribution: US Nationwide distribution.
Product codes and lots: Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2673-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2673-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-30

Product code NFJ

K200132Class IIAshvinsMedicalcommunications GmbH / cleared 2020-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)