Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type
Summary
The FDA issued a Class II for Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 208 by MedicalCommunications GmbH. Reason: Potential that the measured value may be smaller than the actual area..
Details
Source
Device Recall
External ID
Z-2673-2025
Action Date
2025-10-08
Status
Ongoing
Category
device
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)
Lot/Code Info: Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
Quantity Affected: 474 units
Reason for Recall
Potential that the measured value may be smaller than the actual area.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-09
Company
Heidelberg, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MedicalCommunications GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MedicalCommunications GmbH have FDA actions?
This is the only FDA action we have on record for MedicalCommunications GmbH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2673-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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