IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.
- Company
- Agfa Corp.
- Recall Initiated
- June 28, 2007
- Posted
- September 11, 2008
- Terminated
- March 3, 2011
- Recall Number
- Z-1245-2008
- Quantity
- 154 units
- Firm Location
- Greenville, SC
Reason for Recall
Text and Images may not be synchronized.
Distribution
U.S. Nationwide and Canada
Lot / Code Info
Software version IMPAX 6.2.1
Root Cause
Software design
Action Taken
AGFA 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.
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