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U.S. Department of Health and Human Services

Class 2 Device Recall IMAGEnet 6 Ophthalmic Data System

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 Class 2 Device Recall IMAGEnet 6 Ophthalmic Data Systemsee related information
Date Initiated by FirmSeptember 17, 2024
Date PostedNovember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0362-2025
Recall Event ID 95485
510(K)NumberK232828 
Product Classification System, image management, ophthalmic - Product Code NFJ
ProductThe IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.
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FEI Number 2242863
Recalling Firm/
Manufacturer		 Topcon Medical Systems, Inc.
111 Bauer Dr
Oakland NJ 07436-3123
For Additional Information ContactSAME
201-599-5100
Manufacturer Reason
for Recall		The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided
FDA Determined
Cause 2		Software design
ActionTopcon issued Product and Service Bulletin titled: Important notice regarding changes to IMAGEnet 6 for Maestro2 users on 9/17/24 via email. Action Required: In order to comply with recent FDA requirements, changes have been made to the Hood Report for Glaucoma on the Maestro2. You must visit our website to download the software patch for your device. This simple process is designed for customers to complete independently and should take less than 20 minutes to update. Download Software Patch For questions or assistance, please contact customer service at 1-866-922-6278 Mon Fri, 8AM-8PM EST
Quantity in Commerce3144 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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