Intra operative MRI Systems: Neuro II-SE — Class II medical device recall Z-1098-2016
Terminated recall by Deerfield Imaging, reported 2016-03-23, distributed in CA, CT, FL, GA, IL, IN, MA, MD…. Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
| Recall number | Z-1098-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Deerfield Imaging, Minnetonka, MN, United States |
| Recall initiated | 2016-02-10 |
| Classified | 2016-03-11 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2017-04-05 |
| Distributed | CA, CT, FL, GA, IL, IN, MA, MD, MN, MO, NC, NH, OH, OR, PA, TX, UT, VA, WI |
| Countries outside the US | AU, CA, CN, DE, FR, JP |
Product
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
Reason for recall
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
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-1098-2016. 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.