CLASS II ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report
Ashvins variant Heyex 2 / Heyex Pacs recalled by MedicalCommunications
MedicalCommunications is recalling Ashvins variant Heyex 2 / Heyex Pacs, distributed nationwide in the US. The recall was initiated on 9 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2673-2025
- FDA event ID
- 97509
- Recalling firm
- MedicalCommunications, Heidelberg, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Sep 2025
- FDA classified
- 30 Sep 2025
- Reported
- 8 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 9 Sep 2025 | Recall initiated by company | |
| 30 Sep 2025 | Classified by FDA | +21 days |
| 8 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential that the measured value may be smaller than the actual area.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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)
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Potential that the measured value may be smaller than the actual area.
Which lots are affected?
Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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