| Date Initiated by Firm | June 28, 2006 |
|---|
| Date Posted | October 12, 2006 |
|---|
| Recall Status1 |
Terminated 3 on May 10, 2007 |
| Recall Number | Z-0031-2007 |
|---|
| Recall Event ID |
35994 |
| 510(K)Number | K050810 |
|---|
| Product Classification |
Fluoroscopic X-ray system - Product Code MQB
|
| Product | CR DX-S, Image Intensified Fluoroscopic X-ray system. |
|---|
| Code Information |
Units with Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below. |
Recalling Firm/
Manufacturer |
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
|
| For Additional Information Contact | Ray B. Myers Ph.D.
864-421-1806 |
|---|
Manufacturer Reason
for Recall | Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified by letter on/about 06/28/2006. |
|---|
| Quantity in Commerce | 11 units |
|---|
| Distribution | CA, DC, FL, MN, MI, MS, OR. |
|---|
| 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 = MQB
|
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