Recall Z-1098-2016— Deerfield Imaging
Class II · Terminated
Class II FDA medical device recall by Deerfield Imaging, initiated 2016-02-10, terminated 2017-04-05. It names 4 FDA 510(k) clearances: K133692, K083137, K071099 and 1 more. 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: Emergency helium venting lines (i.e. quench lines) may not have been properly installed..
- Recalling firm
- Deerfield Imaging
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-10
- Terminated
- 2017-04-05
- Firm location
- Minnetonka, MN, United States
510(k) clearances named in this recall
4 on FDA's record- K133692 — IMRI 1.5T AND IMRI 3T S
- K083137 — NEURO III-SV
- K071099 — NEURO II-SE, MODELS: OR-DR-OR, OR-MB
- K061916 — NEURO II-SE, MODELS OR-MB-DR AND OR-DR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.