Events

Recall of IC PROFILERMR Model 1123

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sun Nuclear Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69751
  • Event Risk Class
    Class 2
  • Event Number
    Z-0959-2015
  • Event Initiated Date
    2014-08-08
  • Event Date Posted
    2015-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131462
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Has a potential pinch hazard to user performing machine qa in an mri environment.
  • Action
    Sun Nuclear Corp. sent a memo dated 08/08/2014 to their 3 customers of the possible manufacturing error.

Device

IC PROFILERMR Model 1123
  • Model / Serial
    Serial #'s: 92327001, 92327002, 92327003, 84118005, 84118006, 84118004, 84118001, 84118002, and 84118003
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, CO, and OH.
  • 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.
  • Manufacturer
    Sun Nuclear Corporation

Manufacturer

Sun Nuclear Corporation
  • Manufacturer Address
    Sun Nuclear Corporation, 3275 Suntree Blvd, Melbourne FL 32940-7514
  • Manufacturer Parent Company (2017)
    Sun Nuclear Corp.
  • Source
    USFDA