Z-1176-2010

Image Consultant (IC) Software

Name: Z-1176-2010 Image Consultant (IC) Software
Creator: R.O. Gulden & Co., Inc.
Published: 2010-02-05
License: https://open.fda.gov/license/

Gulden Ophthalmics / initiated 2010-02-05 / Terminated / root cause: software

FDA source

R.O. Gulden & Co., Inc. began a recall of Image Consultant (IC) Software on 2010-02-05. The reason FDA records is "Software not validated; inaccurate results may occur". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1176-2010
Status: Terminated
Initiated: 2010-02-05
Posted: 2010-03-22
Terminated: 2010-06-14
Recalling firm: Gulden Ophthalmics
Product: Image Consultant (IC) Software
Product code: NFF Device, Storage, Images, Ophthalmic
Reason for recall: Software not validated; inaccurate results may occur.
Root cause tag: software
FDA root cause: Other
Action: On 2/5/10, the recalling firm issued letters via certified mail to its consignees informing them of the problem and to cease use of the software for diagnosis.
Quantity in commerce: 20
Distribution: The product was shipped to eye doctors/clinics in AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, and WA.
Product codes and lots: product is not coded

Product code NFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)