Recall Z-3028-2017 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are 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, para
| Date | Aug 2, 2017 (initiated May 11, 2017) |
| Status | Terminated |
| Reason | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. |
| Root cause | Mixed-up of materials/components |
| Action | Consignees received a written recall notice dated 05/17/2017 notifying them of a correction to all units using an Uninterruptable Power Supply. Consignees were instructed not to unplug the unit and to continue normal use. Units with the Eaton 9130 Uninterruptable Power Supply connected to the MR operator console would receive a correction at no charge. This would involve possibly replacing the power cable. GE Representatives will be contacting consignees to arrange corrections. Any questions can be directed to GE Healthcare Service at 1-800-437-1171 or your local service representative. |
| Quantity | 68 units in total |
| Distribution | US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT Ge Medical Systems, LLC, Sep 20, 2012 |