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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX 6.5

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  Class 2 Device Recall IMPAX 6.5 see related information
Date Initiated by Firm April 05, 2011
Date Posted May 24, 2011
Recall Status1 Terminated 3 on September 15, 2011
Recall Number Z-2246-2011
Recall Event ID 58565
510(K)Number K022292  
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX 6.5 Client Software.

IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to.
Code Information 35A2Y000, 35AWO000, 5N2N4004, 5NP9X001, 5NSMY000, 5OHXO000, 5QFWU000, E5KN2002, ETQ55000, EU5P6000, EYMFF000, F8AM4771, L18HH000, L2CEW000, L41KH000, L5N26000, L5N4B000, L5N5D000, L5P6O000, L5PD1000, L6S8E000, L8L5U000, L8VHQ000, L9HGC000, LEFG2504, LVTB7007
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Norris
864-421-1754
Manufacturer Reason
for Recall		 Software issue that occurs after dictation of a study.
FDA Determined
Cause 2		 Other
Action Agfa Corp. sent an "URGENT SAFETY NOTICE" customer letter via Agfa email to customers on 4/14/2011, along with a "URGENT SAFETY NOTICE FEEDBACK FORM," The letter identified the product , the problem, and the action to be taken by the customer. It was discovered a software issue in the IMPAX 6.5. The upgrade has already been released to address the software problem. Customers were instructed to fax back the feedback form as soon as possible to (864) 421-1664. If you have any questions, please contact your local Agfa Healthcare organization.
Quantity in Commerce 95 units
Distribution Nationwide Distribution -- including states of WI, and SC.
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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