—#144455

Product

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 functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K143345
Affected lot / code info: Mfg Lot or Serial # System ID 001612TA1 N/A 001718TA6 336397P3T 002331TA7 083132425984 001719TA4 250598MR1 001424TA1 M2850013 001537TA0 TP0008MR07 001662TA6 157022MR01 001184TA1 ZC0002 001652TA7 N/A 002227TA7 ZC0003 002278TA0 ZC0004 002330TA9 ZC0006 002529TA6 N/A 001485TA2 34026MRS05 002279TA8 34225MRS02 002395TA2 34185MRS02

Why it was recalled

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 (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of SC, NC and the countries of Australia, Canada, France. Germany, Japan and Turkey.

Timeline

Recall initiated: 2016-03-01
Terminated: 2016-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144455. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.