| |
Class 2 Device Recall Image Consultant (IC) Software |
 |
| Date Initiated by Firm |
February 05, 2010 |
| Date Posted |
March 22, 2010 |
| Recall Status1 |
Terminated 3 on June 14, 2010 |
| Recall Number |
Z-1176-2010 |
| Recall Event ID |
54633 |
| Product Classification |
Device, storage, images, ophthalmic - Product Code NFF
|
| Product |
Image Consultant (IC) Software |
| Code Information |
product is not coded |
Recalling Firm/
Manufacturer |
R.O. Gulden & Co., Inc.
225 Cadwalader Ave
Elkins Park PA 19027-2020
|
| For Additional Information Contact |
Thomas Cockly
215-884-8105
|
Manufacturer Reason
for Recall |
Software not validated; inaccurate results may occur.
|
FDA Determined
Cause 2 |
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. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|
