FDA Device

IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.

Hazard

Text and Images may not be synchronized.

What You Should Do

Remedy

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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Products

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.
UPC
Software version IMPAX 6.2.1

Units Affected

154 units

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