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U.S. Department of Health and Human Services

Class 3 Device Recall IMPAX Diagnostic Workstation

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  Class 3 Device Recall IMPAX Diagnostic Workstation see related information
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/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D
Manufacturer Reason
for Recall
Possible corrupted image appearing after System Start.
FDA Determined
Cause 2
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.