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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX

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 Class 2 Recall
IMPAX
see related information
Date Posted October 21, 2013
Recall Status1 Terminated on October 24, 2013
Recall Number Z-0035-2014
Recall Event ID 66424
Premarket Notification
510(K) Number
K071297 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Code Information N/A
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Debbie Huff
864-421-1754
Manufacturer Reason
for Recall
System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software in the Use Environment
Action An "URGENT FIELD SAFETY NOTICE" letter was sent via email to the consignees on 9/19/2013, Acknowledgement, via FAX-Back or email, that the information was received and understood has been requested from the consignees. The letter specifically describes the safety alert for the device, informs consignees of the problem and recommends the upgrades for IMPAX and Oracle.
Quantity in Commerce 4
Distribution Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = AGFA HEALTHCARE CORP.
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