GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 215 SIGNA HDx 1.5T and 3.0T magnetic resonance imaging scanners distributed worldwide, including throughout the United States and numerous countries. The issue concerns head and neck scans, where the displayed Specific Absorption Rate (SAR) values—which measure energy absorption by tissue during the scan—may be lower than the actual SAR in the patient's head. According to SAR modeling, the actual SAR in the head could exceed the international safety limit of 3.2 W/kg for some scans.
The record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Reason for recall: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans. Distribution: Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAK Quantity: 215 Lot/code info: 00000275183MR1 609652MR3T 00000848BD5339 2145903TXMRE5 000000HDMR3480 MR98508 000000HDMR5861 865545MR3T 002004-0513-07 617754MR4 002004-0701-18 3137453TMR 000000HDMR2370 NYP347652 002004-0701-15 713704HMR4 000000HDMR3070 517353VH3 00000HDMR20151 313294MR 002004-0917-18 617754MR5 002004-0930-12 615TANMR 002005-0114-20 614722MR3 002005-0127-08 513451MR2 000000000R4044 661CBCCMR 000000HDMR4161 203863MR3T 000000HDMR3916 313593MR3T 002005-0328-17 2709263HD 00000HDMR20114 419383MR3T 000000HDMR2328 7067213TMR 00000930BD5D54 801588MR2 002004-0520-04 615777MR3T 000000HDMR1169 LONGWOOD30MR2 000000HDMR3396 3096653TMR 000000HDMR2818 402552NMC2 000000HDMR2952 415600D3T 00000266754MR1 423844MR2 000000HDMR2721 212305MR83T 000000HDMR3624 RADNETMR1521 00000011015YR5 928317MR1 000000HDMR2854 619543MR2 000000HDMR2481 703478MR5 0948BD61FA 509758TMR 00000275288MR9 831423MR 000000HDMR5864 480425MR5 00000274078MR5 510MIA3T 0000006-0425-3 610433MR 002005-1212-15 602406MR6 00000274744MR2 M48823 00000274745MR9 573815BMR1 000000HDMR5241 406751K3T 00000279999MR7 703573MR5 00000281442MR4 928213MR3T 00000282733MR5 504MCLMR 00000284262MR3 865481MR3T 00000284235MR9 612626MR3T #N/A 269342MR3TCH2 00000285497MR4 517374MR3T 002004-0416-18 415353UMR9 002005-0316-09 850656TD3T 00000282373MR0 408GS3TMR 000000HDMR5569 5853413T 00000300458MR7 RADNETMR594 00000287256MR2 305674MR1 000000HDMR6028 865218MR3T 000000HDMR4230 6109883TMR 00000276721MR8 407BDIMR 00000290478MR7 3017233TMR 00002982315MR9 ALLIANCESIG468 0000093
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.