Recall Z-2673-2025 ยท NFJ System, Image Management, Ophthalmic
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)
| Date | Sep 30, 2025 (initiated Sep 9, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200132 | Ashvins Medicalcommunications GmbH, Feb 18, 2020 |