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FDAAugust 8, 2014device

IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.

What to do

FDA enforcement status: Terminated

Brands named

sun nuclearsun

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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