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Terminated

CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).

FDA Recall Z-0219-2007 · Posted 2006-11-28

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeMBQ
Date Initiated2006-09-01
Date Terminated2008-04-24
Product Quantity178 units

Reason for Recall

Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.

Firm Action

A Service Bulletin to address the issues was created on 09/01/2006. Customers were notified of the plans to upgrade via telephone and email on 10/13/2006.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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