Ashvins variant HEYEX 2 / HEYEX PACS. Software Version recall
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…
Why was Ashvins variant HEYEX 2 / HEYEX PACS. Software Version recalled?
Potential that the measured value may be smaller than the actual area.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
- 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…
- Recalling firm
- MedicalCommunications GmbH
- Quantity
- 474 units
- Distribution
- US Nationwide distribution.
- Recall date
- October 8, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)