Sun Nuclear Corporation recalls IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to mea…
- Recall date
- August 8, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0959-2015
- FDA classification
- Class II
- Brand / firm
- Sun Nuclear Corporation
- Sold / distributed
- Distributed in the states of CA, CO, and OH.
Why it was recalled
Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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