PlainRecordsFDA · Medical device recall
Image Consultant (IC) Software
- Date posted by the FDA
- March 22, 2010
- Status
- Terminated
- Filed by
- R.O. Gulden & Co., Inc.
- Product
- Image Consultant (IC) Software
- Reason
- Software not validated; inaccurate results may occur.
- Distribution pattern
- The product was shipped to eye doctors/clinics in AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, and WA.
- Quantity
- 20
- Codes and lots
- product is not coded
- Recall started
- Feb. 5, 2010
- Device type
- Device, Storage, Images, Ophthalmic
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-1176-2010
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement report, recall number Z-1176-2010. The agency record governs; check it and the company before acting.