Quick Facts at a Glance
- Recall Date
- September 9, 2025
- Hazard Level
- HIGH
- Brand
- MedicalCommunications
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- MedicalCommunications
- Product type
- PACS Software
- Model numbers
- Ashvins variant HEYEX 2 / HEYEX PACS
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 9, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
Ashvins HEYEX 2 / HEYEX PACS is a software-based medical image management system used by imaging departments to store and display diagnostic images.
Why This Is Dangerous
A discrepancy in measurement accuracy could lead to incorrect assessment of areas on imaging studies, potentially impacting clinical decisions.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Hospitals and imaging centers may need to halt specific workflows until remediation. The recall involves 474 US units, potentially affecting diagnostic accuracy.
Practical Guidance
How to identify if yours is affected
- Confirm product is Ashvins HEYEX 2 / HEYEX PACS
- Check software version 2.6.0 to 2.6.8 and UDI-DI 4260648620046
- Verify recall number Z-2673-2025 on FDA notice
- Stop using the device immediately
- Follow manufacturer recall instructions
Where to find product info
FDA recall enforcement report and manufacturer recall communications; UDI on device labeling
What timeline to expect
Remediation timeline not specified; manufacturers typically provide remediation within weeks
If the manufacturer is unresponsive
- Escalate to the FDA through the MedWatch program
- File a complaint with the appropriate health authority
- Document all communications with the manufacturer
How to prevent similar issues
- Ensure software is updated to compatible versions only from trusted sources
- Monitor for recall notices related to medical imaging software
- Verify UDI-DI during procurement and after updates
- Maintain up-to-date contact information with device vendor and hospital compliance
Documentation advice
Keep copy of recall notice, email communications, device labels, UDI-DI, and software version records for audits and claims
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Product Details
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)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 474 units recalled in US nationwide distribution
- Affected software versions 2.6.0 (Build 2088) to 2.6.8 (Build 2220)
- Hazard: measured value may be smaller than actual area
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Safety Guide
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