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Specifically, the Z Vent Ventilator "was evaluated to test for MRI compatibility only by using the 3T MRI scanner" with "no rationale or justification for lack of testing with the 1.5T MRI scanner." The labeling specified placement behind the 130 Gauss field line for 3T MRI magnets but"fails to specify how far the ventilator should be placed when using 1.5T MRI

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Early animal and small human studies suggest it is generally well tolerated in the short term, but we do not yet have large, longterm trials