GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Si
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 82 magnetic resonance (MR) imaging systems worldwide, including 39 in the USA and 43 internationally across 21 countries. The affected systems are various models including Signa Infinity MR System, Signa MR/i MR System, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, and Signa 3T Infinity. The problem involves a gradient cable in the ACGD cabinet that may be missing a spacer, which normally prevents the gradient cable terminals from being connected with incorrect polarity to the X gradient amplifier.
If the cable terminals are connected in the wrong polarity due to the missing spacer, MR images could be flipped left-right with incorrect orientation annotation, potentially affecting the accuracy of diagnostic imaging. The recalled systems are identified by specific manufacturer lot and serial numbers listed in the recall details. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.
Reason for recall: A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation. Distribution: Worldwide Distribution - US (nationwide) and Internationally to UNITED ARAB EMIRATES, ARGENTINA, BRAZIL, INDIA, EGYPT, CHINA, FINLAND, FRANCE, UNITED KINGDOM, HUNGARY, JAPAN, INDONESIA, KOREA, MEXICO, NEW ZEALAND, CANADA, AUSTRALIA, ITALY, RUSSIAN FEDERATION, TAIWAN, and SOUTH AFRICA. Quantity: 82 (39 USA; 43 OUS) Lot/code info: Mfg Lot or Serial # System ID 00000153282MR9 501362MR1 00000165901MR0 ZA2101MR02 00000213818MR8 37190MRI 00000213341MR1 M27590 00000247386MR6 707459MR2 00000231538MR0 706583MR 00000236418MR0 850862FTS1CH1 00000242668MR2 502868MR 00000267704MR5 314525SAMR2 00000227724MR2 ALLIANCESIG262 00000214667MR8 853270051 00000242173MR3 ALLIANCESIG287 00000241518MR0 502633MR1 00000231910MR1 212956MR2 00000237000MR5 0910272037 00000241867MR1 HU1008MR01 00000243769MR7 920279006 00000047514WH5 YM0774 00000285490MR9 954916MR1 00000284687MR1 309655MRI1A 00000280860MR8 1202470 00000282692MR3 902496MRI3 00000282813MR5 0835270010 00000278669MR7 508755MR1 00000267211MR1 0850270458 000000HDMR3141 SHIMR598 000000HDMR5777 919470MR2 000000HDMR3905 709737MRI 000000HDMR2541 M4018076 000000HDMR5379 M4135138 00000HDMR10710 10543MRM01 00000301019MR6 SMSDML2 00000292334MR0 INSIGHTMR1915 00000290735MR0 704323MR1 00000300812MR5 MR14604YR3 00000297420MR2 082427080028 00000239401MR3 404352PNC 00000209414MR2 732591MR 00000206394MR9 516365MR 00000224271MR7 RADNETMR1515 00000190316MR0 1167491 00000223494MR6 1299290 00000223256MR9 84631 00000227239MR1 2817688 00000230273MR5 2817679 00000240274MR1 083027002100393 00000199094MR4 YM0620 00000237547MR5 600101MR01 00000210080MR8 941262MR 00000214332MR9 208367LX5 00000204255MR4 770438EAMR 00000218279MR8 2214SIGNA15 00000215878MR0 0853270047 00000193672MR3 AE1011MR01 00000001634M25 MRR8049 00000005464M23 082427070113 00000000108M21 2807539 00000267104MR8 864225MR 00000254
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.