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Terminated

DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.

FDA Recall Z-0464-2011 · Posted 2010-11-26

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeMQB
Date Initiated2010-10-08
Date Terminated2010-12-30
Product QuantityOne unit

Reason for Recall

Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.

Firm Action

Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.

Root Cause

Other

Distribution Pattern

Nationside Distribution: to NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092238AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERSAgfa Healthcare N.V. · 2009-08-11

Official Source

View FDA Recall →

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

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