AGFA Corp. IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.
Brand
AGFA Corp.
Lot Codes / Batch Numbers
Software version IMPAX 6.2.1
Products Sold
Software version IMPAX 6.2.1
AGFA Corp. is recalling IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, trans due to Text and Images may not be synchronized.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Text and Images may not be synchronized.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026