Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic res
FDA device recall Z-1098-2016 · posted 2016-03-11 · Terminated
Recall details
- Recalling firm
- Deerfield Imaging
- Reason for recall
- Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
- Action taken
- 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 +1-866-475-0525.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 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 GER
- Date initiated
- 2016-02-10
- Date posted
- 2016-03-11
- Date terminated
- 2017-04-05
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMRI 1.5T AND IMRI 3T S (K133692) | Imris, Inc. | 2014-02-10 |
| NEURO III-SV (K083137) | Imris, Inc. | 2008-12-16 |
| NEURO II-SE, MODELS: OR-DR-OR, OR-MB (K071099) | Imris, Inc. | 2007-05-22 |
| NEURO II-SE, MODELS OR-MB-DR AND OR-DR (K061916) | Imris, Inc. | 2006-08-11 |