| Date Initiated by Firm | June 18, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on September 03, 2004 |
| Recall Number | Z-1036-04 |
|---|
| Recall Event ID |
29375 |
| 510(K)Number | K850959 |
|---|
| Product Classification |
System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
|
| Product | Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA. |
|---|
| Code Information |
Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154 |
| FEI Number |
1037885
|
Recalling Firm/
Manufacturer |
Advance Medical Designs Inc
1241 Atlanta Industrial Dr
Marietta GA 30066-6606
|
| For Additional Information Contact | Mr. Mike Tomberlin
770-422-3125 Ext. 243 |
|---|
Manufacturer Reason
for Recall | The product may come apart when excessive force is applied to the coupler. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified on 6/17/2004 first by telephone on 6/17/2004 with f/u letter sent 6/18/04. |
|---|
| Quantity in Commerce | 2340 units, *amended to include additional 250 units |
|---|
| Distribution | Nationwide and Canada |
|---|
| 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.
|
| 510(K) Database | 510(K)s with Product Code = JAA
|
|---|
