HIGH

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...

Potential that the measured value may be smaller than the actual area.

Hazard Information

Potential that the measured value may be smaller than the actual area.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact MedicalCommunications GmbH or your healthcare provider for instructions. Notification method: E-Mail

Full 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: Potential that the measured value may be smaller than the actual area.. Classification: Class II. Quantity: 474 units. Distribution: US Nationwide distribution.

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Product Classification

Product Details

Model Numbers
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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