Ashvins variant HEYEX 2 / HEYEX PACS. Software Version:… recallZ-2673-2025 · MedicalCommunications GmbH · initiated Sep 9, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MedicalCommunications GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential that the measured value may be smaller than the actual area.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2673-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 9, 2025
- Posted by the FDA
- Sep 30, 2025
- Recalling firm
- MedicalCommunications GmbH
- Quantity
- 474 units
- Product code
- NFJ
- FDA submissions
- K200132
- Distribution
- US Nationwide distribution.
Product description
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)
Code information (models, lots, serial numbers)
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ashvins variant HEYEX 2 / HEYEX PACS 2.6MedicalCommunications GmbH · System, Image Management, Ophthalmic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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