Recall – Patient data system may display incorrect information

Company: Topcon Medical Systems, Inc.
Date of Enforcement Report: 4/24/2019
Class II:

PRODUCT

IMAGEnet 6 v1.53- 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 without controlling or altering the functions and parameters of any medical devices or through computerized networks.

Recall Number: Z-1138-2019

REASON

When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient’s thumbnails is completed, then the primary patient’s thumbnails are displayed with secondary patient’s identification information such as name, patient’s ID, etc. on the monitor screen of the PC used.

RECALLING FIRM/MANUFACTURER

Topcon Medical Systems, Inc. on 3/6/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
450 units

DISTRIBUTION

US Nationwide

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.