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
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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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