| Date Initiated by Firm | August 08, 2006 |
|---|
| Date Posted | October 12, 2006 |
|---|
| Recall Status1 |
Terminated 3 on February 20, 2007 |
| Recall Number | Z-0033-2007 |
|---|
| Recall Event ID |
36203 |
| 510(K)Number | K022292 |
|---|
| Product Classification |
mammography - Product Code LLZ
|
| Product | IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) |
|---|
| Code Information |
Diagnostic Workstation/Impax 5.2/with CAD Capability/Flat Panel 60+00024433, Diagnostic Workstation/Impax 5.2/with CAD Capability/CRT: 60+00024432 and Clinical Review Station/Impax 5.2/with CAD Capability/Flat Panel: 60+00024438. Software version Impax 5.2.2 sites using CAD. |
Recalling Firm/
Manufacturer |
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
|
| For Additional Information Contact | Ray B. Myers Ph.D.
864-828-1827 |
|---|
Manufacturer Reason
for Recall | Failed CAD displayed as 'No Findings' |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified by letter on/about 08/08/2006. |
|---|
| Quantity in Commerce | 20 Impax 5.2 Mammo licenses were issued domestically. |
|---|
| Distribution | Nationwide. |
|---|
| 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 = LLZ
|
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