Reported Aug 12, 2015 · Terminated
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa…
GE Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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, Signa HDxt, Signa HDi. Whole body magnetic resonance diagnostic imaging scanners.
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 00000297420MR208242708002800000239401MR3 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 00000005464M2308242707011300000000108M21 2807539 00000267104MR8 864225MR 00000254183MR7 304347MR1 00000264011MR8 EG1522MR01 00000006705YR8 901226MR1 00000007870YR9 2651831 00000009552YR1 FI1012MR04 00000009010YR0 FI1012MR03 00000006662YR1 0850270197 002003-0922-09 ALLIANCESIG293 0002005-0725-4 5360MREXCITE3 00000279502MR9 304766TMR 00000284315MR9 208265BMR 00000285664MR9 904399MR2 00000280274MR2 561798MR1 00000286778MR6 2718385 00000276273MR0 4716MREXCITE 00000299465MR5 EG1279MR01 00000309342MR408242701007700000264527MR3 SMSFFI2 00000263933MR4 A5156029 00000266764MR0 RADNETMR1513 00000291209MR5 415780KMR 00000290984MR4 214820XBMR1 928649MR08302703148203— - Amount recalled
- 82 (39 USA; 43 OUS)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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