Z-0959-2015 Class II Terminated

Recalled by Sun Nuclear Corporation — Melbourne, FL

Recall Details

Product Type
Devices
Report Date
January 21, 2015
Initiation Date
August 8, 2014
Termination Date
March 23, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 Units.

Product Description

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.

Reason for Recall

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

Distribution Pattern

Distributed in the states of CA, CO, and OH.

Code Information

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