Recall Z-1098-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
Deerfield Imaging
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).
| Date | Mar 11, 2016 (initiated Feb 10, 2016) |
| Status | Terminated |
| Reason | Emergency helium venting lines (i.e. quench lines) may not have been properly installed. |
| Root cause | Device Design |
| Action | Consignees were sent a IMRIS "Urgent Field Safety Notice" letter dated February 10, 2016. The letter described the problem and the product involved in the recall. The firm also stated that it is important that customers review the portion of the quench line vent described and ensure that it is installed to the specifications supplied as part of the Planning Guide. Customers were reminded that it is important to have an emergency plan in place in the event Helium gas escapes into the magnet room or any other area. For questions customers can contact their local customer support hotline or |
| Quantity | 35 USA, 14 OUS |
| Distribution | 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. |
| FDA record | Open on fda.gov |