Z-2673-2025 Class II Ongoing
FDA device recall Z-2673-2025 was initiated by MedicalCommunications GmbH on September 9, 2025 and is designated Class II. Reason for recall: Potential that the measured value may be smaller than the actual area. The recall status is ongoing. Affected quantity: 474 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- September 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 474 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).