Recall Z-2673-2025— MedicalCommunications GmbH
Class II · Ongoing
Class II FDA medical device recall by MedicalCommunications GmbH, initiated 2025-09-09. It names one FDA 510(k) clearance: K200132. 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). Reason: Potential that the measured value may be smaller than the actual area..
- Recalling firm
- MedicalCommunications GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-09
- Firm location
- Heidelberg, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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)
Reason for recall
Potential that the measured value may be smaller than the actual area.
Data sourced from openFDA. This site is unofficial and independent of the FDA.