Class 2 Device Recall IC PROFILERMR Model 1123

• Date Initiated by Firm: August 08, 2014
• Date Posted: January 13, 2015
• Recall Status: Terminated 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: 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.