Recall Z-1347-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or func
| Date | Mar 1, 2016 |
| Status | Terminated |
| Reason | Ferrous material in the SIGNA Pioneer Table Control Box (TCB) could cause unexpected attraction to the MR system's high strength magnetic field during servicing activities. This could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the TCB from the magnetic field. There have been no events reported as a result of this issue. Clinical scanni |
| Root cause | Labeling Change Control |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 68002 dated March 1, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions or concerns regarding this notification,contact GE Healthcare Service at 18004371171 or your local Service Representative. |
| Quantity | 16 (2 US; 14 OUS) |
| Distribution | Worldwide Distribution - US Nationwide in the states of SC, NC and the countries of Australia, Canada, France. Germany, Japan and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143345 | SIGNA Pioneer Ge Healthcare Japan Corporation, Jul 10, 2015 |