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Terminated

Definium 5000 X-ray System, model number 5220493 and 5220393-2

FDA Recall Z-1118-2009 · Posted 2009-09-25

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2009-03-24
Date Terminated2012-05-16
Product Quantity85

Reason for Recall

A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure.

Firm Action

A notification was sent to all affected customer sites alerting them to this issue, with instructions for safe use of the affected systems.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063283DEFINIUM 5000 X-RAY SYSTEMSedecal., Sa. · 2006-11-17

Official Source

View FDA Recall →

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

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