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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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