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U.S. Department of Health and Human Services

Class 2 Device Recall Ashvins

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 Class 2 Device Recall Ashvinssee related information
Date Initiated by FirmSeptember 09, 2025
Date PostedSeptember 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2673-2025
Recall Event ID 97509
510(K)NumberK200132 
Product Classification System, image management, ophthalmic - Product Code NFJ
ProductAshvins 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)
Code Information Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
FEI Number 3003995303
Recalling Firm/
Manufacturer		 MedicalCommunications GmbH
Max-Jarecki-Str. 8
Heidelberg Germany
For Additional Information ContactKenneth Barron
US-800-931-2230
Manufacturer Reason
for Recall		Potential that the measured value may be smaller than the actual area.
FDA Determined
Cause 2		Software design
ActionAshvins notified consignees on about 09/09/2025 via emailed letter. Consignees were instructed to cease using the freeform measurement function in the MMV until the software update has been performed, which is now available. Consignees were instructed to perform the update as soon as possible, complete the digital Field Safety Notice Acknowledgement and Receipt Form, and maintain a copy of the letter and the user manual with the device until the software update is complete.
Quantity in Commerce474 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NFJ
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