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Recall Observatory FDA recall evidence

Device product

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.

Z-0959-2015

August 08, 2014

Class II

Product summary

Firm
Sun Nuclear Corporation
Event
Event 69751
Status
Terminated
Classification
Class II
Quantity
6 Units.
Official record key
device-enforcement:Z-0959-2015

Official wording

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

Code information: Serial #'s: 92327001, 92327002, 92327003, 84118005, 84118006, 84118004, 84118001, 84118002, and 84118003

Distribution pattern: Distributed in the states of CA, CO, and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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