Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: S
FDA device recall Z-2673-2025 · posted 2025-09-30 · Open, Classified
Recall details
- Recalling firm
- MedicalCommunications GmbH
- Reason for recall
- Potential that the measured value may be smaller than the actual area.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- NFJ
- Quantity affected
- 474 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-09-09
- Date posted
- 2025-09-30
- Location
- Heidelberg, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ashvins (K200132) | Medicalcommunications GmbH | 2020-02-18 |