Topcon Medical Systems, Inc. recalls The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of…
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…
Read the official notice →- Date
- 2024-11-20
- Country
- United States
- Brand
- Topcon Medical Systems, Inc.
- Product
- The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital…
- Classification
- Class II
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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