FDA Device recall Z-0959-2015
IC PROFILER-MR - Model 1123
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of IC PROFILER-MR - Model 1123 by Sun Nuclear, citing has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0959-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-08 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sun Nuclear |
| Distribution | CA, CO, OH |
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.
Reason
Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
Identifiers
| code_info | Serial #'s: 92327001, 92327002, 92327003, 84118005, 84118006, 84118004, 84118001, 84118002, and 84118003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0959-2015%22
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