Medical device recalls Moderate risk

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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