Reported Mar 23, 2016 · Terminated
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic…
Deerfield Imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Deerfield Imaging · 5101 Shady Oak Rd S · Minnetonka, MN · 55343-4100
Is this the product you have?
- Intra operative MRI SystemsNeuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD)
- Lot codes and dates
7003610076-21M0000410073-012352940481M00152M0000530445M0016906001410043-00308231000468010050-01406623093531084312031000222140510406133071931046309103083230623312131000415210072-013125040815310493006840412M0038M00106M0036710035-0140475404951000749810005946402634068810058-004061931085and 10005639
- Amount recalled
- 35 USA, 14 OUS
Where it was sold
Why it was recalled
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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