GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is 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 the SIGNA HDx 3.0T magnetic resonance imaging system, a whole body scanner used for diagnostic imaging. The recall affects 350 devices distributed worldwide, including across the United States and numerous countries in Europe, Asia, Africa, the Middle East, and the Americas. The issue involves inaccurate readings during head and neck scans.
During head or neck scans, the system's displayed SAR (specific absorption rate) values may be lower than the actual SAR energy being absorbed in the patient's head. According to SAR modeling predictions, the actual SAR in the head could exceed the international safety limit of 3.2 W/kg established in IEC60601-2-33 for some scans. The recall notice does not specify what action affected consumers should take.
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: 350 Lot/code info: 002003-0922-04 713441MR5 1583678 732632MR3 002003-1015-09 713441MR7 00001009BD6576 713792AMR12 000000HDMR5656 417269MRS1 00000HDMR10766 623433MR1 00000265552MR0 9525413TMR 00000026005MR8 503215MR1 002004-1102-17 7705353TMR 00000265805MR2 ACB41121MR HDMR5274 CBICMR1 0002005-0606-3 615284MR3T 000000HDMR5581 503216MR3 000000HDMR2301 269342MR3T 000000HDMR3234 303340MR 00000273869MR8 214345SWD3TMR1 000000HDMR2559 805GI3T HDMR2980 732223MR 00000275049MR5 706UGA3T 00000275649MR2 719595MR 00000275647MR6 3173383T1 #N/A 919684MR3 00000276435MR5 901226MR1 1002BD63EF 719542MR 00000275050MR3 631427MR3T 00000276722MR6 5857853T #N/A 5857853TTIP 00000273253MR5 717975MR3 00000007498YR9 212288GE3T 00000275967MR8 850916A3T 00000275648MR4 908725MR 00000278851MR1 425297RMR 00000006726YR4 COR373216 HM3652 715839MR3T 00000007556YR4 210617TCAMR2 00000HDMR10718 773665MR3T 00000278679MR6 708383WS3T 00000279918MR7 515643MR3T 00000279614MR2 904996MR3T 00000271119MR0 513556MR 00000280000MR1 630CDH3T 00000278678MR8 916KM3TMR 00000279613MR4 516562MR3T 00000279068MR1 805569MR 00000281154MR5 COR373219 00000282007MR4 4047783TMR 00000280949MR9 720848MR2 00000281342MR6 404772NMR3T 00000275646MR8 901572L3T 00000282796MR2 6622343TMR 00000280948MR1 650FALK3TMR 00000282731MR9 509474SH3T 00000280947MR3 2063203TMR 00000280670MR1 813251MR3T 00000276718MR4 MR129033 00000028261MR4 214433TN3TMR 00000282371MR4 7654493T 00000275650MR0 731935MR3 000000HDMR5671 323442MR3 000000HDMR3333 801IMCMR3 00000287415MR4 BEV3TMR 000002
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.