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Terminated

CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)

FDA Recall Z-0353-06 · Posted 2006-01-06

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2005-11-18
Date Terminated2009-06-30
Product Quantity2630 units

Reason for Recall

Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.

Firm Action

Consignees will be notified by letter on/about December 1, 2005 and offered upgraded software.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010571ADC QS/IPD WORKSTATIONAgfa Corp. · 2001-03-28

Official Source

View FDA Recall →

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

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