Z-0959-2015Class II

IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical...

Name: Z-0959-2015 IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical...
Creator: Sun Nuclear Corporation
Published: 2014-08-08
License: https://open.fda.gov/license/

Sun Nuclear Corporation / initiated 2014-08-08 / Terminated

FDA source

Sun Nuclear Corporation began a recall of IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic... on 2014-08-08. FDA classified it as Class II and gives the reason as "Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0959-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-08
Posted: 2015-01-13
Terminated: 2015-03-23
Recalling firm: Sun Nuclear Corporation
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
FDA root 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.
Product codes and lots: Serial #'s: 92327001, 92327002, 92327003, 84118005, 84118006, 84118004, 84118001, 84118002, and 84118003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0959-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0959-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-13

Product code IYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)