Date Initiated by Firm |
June 30, 2006 |
Date Posted |
July 27, 2006 |
Recall Status1 |
Terminated 3 on September 05, 2006 |
Recall Number |
Z-1256-06 |
Recall Event ID |
35821 |
510(K)Number |
K022292
|
Product Classification |
System, Image Processing, Radiological - Product Code LLZ
|
Product |
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images. |
Code Information |
All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08 installed. |
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 |
Possible corrupted image appearing after System Start.
|
FDA Determined Cause 2 |
Other |
Action |
On 06/30/2006 Agfa upgraded the Software on the installed units using a Mandatory Service Bulletin DD+DIS225.06E. |
Quantity in Commerce |
2 units |
Distribution |
NY |
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 and Original Applicant = AGFA CORP.
|