Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator''s console.
FDA Recall Z-0219-05 · Posted 2006-02-14
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Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2004-12-30
Date Terminated2006-02-21
Product Quantity2716
Reason for Recall
Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
Firm Action
An 'Urgent: Radiation Safety Notice' letter was issued to hospitals with affected systems describing potential hazards, the planned modification and recommended action to limit the hazard until the planned modification is installed. A GE field Service Representative will install the modification.
Root Cause
Other
Distribution Pattern
globally
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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