Z-1098-2016 Class II Terminated
FDA device recall Z-1098-2016 was initiated by Deerfield Imaging on Feb 10, 2016 and is designated Class II. Reason for recall: Emergency helium venting lines (i.e. quench lines) may not have been properly installed. The recall status is terminated (terminated Apr 5, 2017). Affected quantity: 35 USA, 14 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2016
- Initiation Date
- Feb 10, 2016
- Termination Date
- Apr 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 USA, 14 OUS
Product Description
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.
Distribution Pattern
Worldwide Distribution -- US, including the states of CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX, UT, VA, and WI; and ,countries of CHINA, CANADA, AUSTRALIA, FRANCE, JAPAN, and GERMANY.
Code Information
70036, 10076-21, M00004, 10073-01, 23529, 40481, M00152, M00005, 30445, M00169, 060014, 10043-00, 30823, 10004680, 10050-01, 40662, 30935, 31084, 31203, 10002221, 40510, 40613, 30719, 31046, 30910, 30832, 30623, 31213, 10004152, 10072-01, 31250, 40815, 31049, 30068, 40412, M0038, M00106, M00367, 10035-01, 40475, 40495, 10007498, 10005946, 40263, 40688, 10058-00, 40619, 31085, and 10005639.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1098-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026