MedicalCommunications GmbH recalled 474 Ashvins HEYEX 2 / HEYEX PACS software units distributed nationwide in the United States. The affected software versions range from 2.6.0 (Build 2088) to 2.6.8 (Build 2220). The hazard is that the measured value may be smaller than the actual area, potentially affecting imaging measurements. Stop using the software immediately and follow manufacturer recall‑s
Potential that the measured value may be smaller than the actual area.
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
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Ashvins HEYEX 2 / HEYEX PACS is a software-based medical image management system used by imaging departments to store and display diagnostic images.
A discrepancy in measurement accuracy could lead to incorrect assessment of areas on imaging studies, potentially impacting clinical decisions.
This recall is not identified as part of a broader industry pattern.
Hospitals and imaging centers may need to halt specific workflows until remediation. The recall involves 474 US units, potentially affecting diagnostic accuracy.
FDA recall enforcement report and manufacturer recall communications; UDI on device labeling
Remediation timeline not specified; manufacturers typically provide remediation within weeks
Keep copy of recall notice, email communications, device labels, UDI-DI, and software version records for audits and claims
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS\nUDI-DI: 4260648620046\nSoftware Versions: 2.6.0 (Build 2088) to 2.6.8 (Build 2220)\nDistribution: US Nationwide\nQuantity: 474 units\nBrand: MedicalCommunications GmbH (brand standardized to MedicalCommunications)
No injuries or incidents have been reported.
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