IC PROFILER-MR — Class II medical device recall Z-0959-2015
Terminated recall by Sun Nuclear Corporation, reported 2015-01-21, distributed in CA, CO, OH. Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
| Recall number | Z-0959-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Nuclear Corporation, Melbourne, FL, United States |
| Recall initiated | 2014-08-08 |
| Classified | 2015-01-13 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-03-23 |
| Distributed | CA, CO, OH |
| Quantity | 6 units |
| Serial numbers | 84118001, 84118002, 84118003, 84118004, 84118005, 84118006, 92327001, 92327002, 92327003 |
| Model numbers | 1123 |
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 for recall
Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0959-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.