GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling the Signa Profile EXCITE MR system, an open whole-body diagnostic imaging scanner. During head or neck scans, the displayed Specific Absorption Rate (SAR) values may be lower than the actual SAR in the head based on SAR modeling. The modeling indicates that the actual head SAR could exceed the international safety limit of 3.2 W/kg for some scans, meaning patients could receive higher radiofrequency energy exposure than what the system displays.
Approximately 97 systems have been distributed worldwide, including throughout the United States and territories, as well as numerous countries internationally. The recall 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: 97 Lot/code info: 002005-1018-15 352333MR3T 000006-0523-13 716859MR3T 00001003BD6425 352376MR3T2 00000280001MR9 MR129031 00000285499MR0 2154563TMR 000000HDMR3702 RADNETMR554 00000274930MR7 805CHLIMR1 00000280057MR1 513558MR3T 00000274998MR4 213977MR2 002004-0713-06 ACB41109MR 002004-0406-08 323442MR2 002004-0406-15 323442MR1 00000273396MR2 7326133T 002004-1115-19 865373MR1 002005-0316-05 7576713T 0002005-0606-4 205750MR2 00000274839MR0 9287573TMR 002006-0119-15 559325CIIMR1 0002005-1201-3 256734MR3T 002005-1003-15 201487MR 000000HDMR2996 6053223TMR 000000HDMR3245 775RDC3T 002005-0620-16 405634S3T 00000269460MR2 602406IMR 00000275670MR8 813972VAMR 0002005-1121-7 480614MR1 00000273230MR3 602689MR1 002005-1201-20 601288MR3T 00000275936MR3 ALLIANCESIG463 00000275086MR7 650306SMR3T 00000275162MR6 772VRAMR3T 00000273459MR8 360397MR2 0002005-0104-5 662841MR4 000006-0511-20 336852SEMR 00000278626MR7 228KAFBMR3T 00000278619MR2 806212MR3T 00000278722MR4 337261MR1 00000281703MR9 916DR3TMR 0002005-0511-5 203797MR3T 002005-1115-04 615342MR3T 00000282868MR9 504873TMR3 00000281682MR5 859275MR3T 000000HDMR5653 RADNETMR608 00000000036657 480584MR1 #N/A TRAINING789 N/A 201669MR2 00000278623MR4 972378NSC3TMR1 00000267322MR6 920568MR3T 00000273365MR7 503280MR2 0002005-1201-6 865541MR3T 00000086257DP3 901516U3T 00000264748MR5 0910277003 00000268123MR7 0910272046 AZ1003MR02 00000282790MR5 082427090245 00000285380MR2 082427100084 00000286559MR0 082427090090 00000286800MR8 082427100089 00000287879MR1 082427040076 000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.