IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is recall
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…
Why was IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
System Version 1.53
- 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…
- Recalling firm
- Topcon Medical Systems, Inc.
- Quantity
- 450 units
- Distribution
- Nationwide
- Recall date
- April 24, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)