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Terminated

CR DX-S, Image Intensified Fluoroscopic X-ray system.

FDA Recall Z-0031-2007 · Posted 2006-10-12

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeMQB
Date Initiated2006-06-28
Date Terminated2007-05-10
Product Quantity11 units

Reason for Recall

Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.

Firm Action

Consignees were notified by letter on/about 06/28/2006.

Root Cause

Other

Distribution Pattern

CA, DC, FL, MN, MI, MS, OR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050810AGFA CR50.0Agfa Corp. · 2005-04-21

Official Source

View FDA Recall →

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

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