GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F System. It is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 89 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32 cm or 40 cm image intensifier.
FDA Recall Z-1564-2008 · Posted 2008-08-24
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Reason for Recall
Firm Action
Root Cause
Device Design
Distribution Pattern
(USA) AK CO IL LA MA MI MS NC NJ NY PA SC TN UT VA WA WI (OUSA) BR CA MX AU C3 KR PH TW AE AT BE BF BG CM CY CZ DE ES FI FR GB GE GR GY HR HU IT LB LV MT NA NG PL PT RO RU SA SD SE SI SK SY TN TR UA YU ZA
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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