Recall Z-0236-2019 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
SIGNA Architect system Product Usage: The Signa Architect system 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/
| Date | Oct 3, 2018 |
| Status | Terminated |
| Reason | A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. |
| Root cause | Device Design |
| Action | On about 10/03/2018, GE Healthcare sent URGENT MEDICAL DEVICE CORRECTION letters to their consignees informing them of recall and providing safety instructions. Consignees were instructed that they can continue to use the system by following the existing Operator Manual Safety Information for proper patient padding and observation during scanning. The safety information contained in the Operator's Manual includes: 1. WARNING: Place appropriate non-conductive padding between the patient and the bore wherever a portion of the body may come into contact with the magnet opening. 2. CAUTI |
| Quantity | 4 units |
| Distribution | Worldwide - US Nationwide Distribution in the state of Utah. International distribution to France, Republic of Korea, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T Ge Medical Systems, LLC, Jun 9, 2016 |