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U.S. Department of Health and Human Services

Class 2 Device Recall IC PROFILERMR Model 1123

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  Class 2 Device Recall IC PROFILERMR Model 1123 see related information
Date Initiated by Firm August 08, 2014
Date Posted January 13, 2015
Recall Status1 Terminated 3 on March 23, 2015
Recall Number Z-0959-2015
Recall Event ID 69751
Product Classification Accelerator, linear, medical - Product Code IYE
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.
Code Information Serial #'s: 92327001, 92327002, 92327003, 84118005, 84118006, 84118004, 84118001, 84118002, and 84118003
Recalling Firm/
Manufacturer
Sun Nuclear Corporation
3275 Suntree Blvd
Melbourne FL 32940-7514
For Additional Information Contact Jeff Kapatoes
321-259-6862 Ext. 322
Manufacturer Reason
for Recall
Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
FDA Determined
Cause 2
Use error
Action Sun Nuclear Corp. sent a memo dated 08/08/2014 to their 3 customers of the possible manufacturing error.
Quantity in Commerce 6 Units.
Distribution Distributed in the states of CA, CO, and OH.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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