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Terminated

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

FDA Recall Z-1245-2008 · Posted 2008-09-11

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-06-28
Date Terminated2011-03-03
Product Quantity154 units

Reason for Recall

Text and Images may not be synchronized.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

U.S. Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.XAgfa Corp. · 2005-04-21K040555IMPAX CLIENT EMBRACEAgfa Corp. · 2004-05-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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