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U.S. Department of Health and Human Services

Class 3 Device Recall IMPAX Clients 6.x

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  Class 3 Device Recall IMPAX Clients 6.x see related information
Date Initiated by Firm June 04, 2008
Date Posted September 04, 2008
Recall Status1 Terminated 3 on October 09, 2009
Recall Number Z-2180-2008
Recall Event ID 48632
510(K)Number K022292  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Impax¿ 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. The Impax Systems are Picture Archiving and Communications system (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images.
Code Information Catalog Numbers for Impax 6.x Client Software: Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+000250353, Product Code: L8DTC; Breast Imaging Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+00025055, Product Code: L8DGM; Orthopeadic Viewer - R6 Concurrent User, Package Code: 60+00025056, Product Code: L8DEH, L4NVL; Radiologist w/QC Viewer - Concurrent User: Product Code: EW43C; Breast Imaging Radiologist w/QC Viewer - Concurrent User, Product Code: EW44E; Enterprise Viewer - Concurrent License, Product Code: L8DP3; Impax¿ 6 Orthopeadic Center Client Site License, Product Code: EW21Y; Impax¿ 6 Site License (includes client site license above - L8FEQ), Package Code: 60+00025123, and Product Code: L8FEQ.
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		 The IMPAX client failed to "refresh" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the "active" study.
FDA Determined
Cause 2		 Software design
Action An "Urgent Safety Notice" letter was sent to all the sites using potentially affected units on/about June 4, 2008. Dealers were notified via letter on June 9, 2008. The letter requests that all users be reminded that Agfa recommends the system is configured so that demographic information is not removed from the image viewing area. They will be provided with the appropriate Service Update, based on the current version of IMPAX Client 6.x in use at their site. They were advised to distribute the information within their facility to all those who need to be aware of it. A FAX Back form was requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. Contact AGFA at 1-877-777-2432, prompts 1, 2, 1.
Quantity in Commerce 371 units
Distribution U.S., Canada, Europe, Asia Pacific and Latin America.
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.
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