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Terminated

CR DX-S, DX-S, Computed radiography system (Digitizer)

FDA Recall Z-0855-06 · Posted 2006-05-09

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeMQB
Date Initiated2005-11-03
Date Terminated2006-06-20
Product Quantity3 units

Reason for Recall

Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.

Firm Action

Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts.

Root Cause

Other

Distribution Pattern

DC, MS, OR--three states

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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