FDA Medical Device Recalls (openFDA)
R.O. Gulden & Co., Inc.: Image Consultant (IC) Software
- Recall number
- Z-1176-2010
- Recalling firm
- R.O. Gulden & Co., Inc.
- Product
- Image Consultant (IC) Software
- Status
- Terminated
- Initiated
- 2010-02-05
- Posted
- 2010-03-22
- Terminated
- 2010-06-14
- Reason
- Software not validated; inaccurate results may occur.
- 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
- 20
- Distribution
- The product was shipped to eye doctors/clinics in AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, and WA.
- Lot, serial or model codes
- product is not coded
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NFF
- Firm FEI
- 2518410
- Firm city
- Elkins Park
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28