Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX 6.2.1

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall IMPAX 6.2.1see related information
Date Initiated by FirmJune 28, 2007
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on March 03, 2011
Recall NumberZ-1245-2008
Recall Event ID 46386
510(K)NumberK040555 K050751 
Product Classification Picture Archiving and Communications system - Product Code LLZ
ProductIMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.
Code Information Software version IMPAX 6.2.1
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information ContactRay B. Myers Ph.D.
864-421-1815
Manufacturer Reason
for Recall		Text and Images may not be synchronized.
FDA Determined
Cause 2		Software design
ActionAGFA notified all consignees via registered letter on/about 06/28/2007 informing them of the potential problem and requesting the accounts ensure the visual synchronization indicators in the Text and Image Areas are used to verify the synchronization status of the Text and Image Areas. 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. A Mandatory Service Bulletin was deployed to correct the problem in the software.
Quantity in Commerce154 units
DistributionU.S. Nationwide and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
-
-