Signa Excite" 1.5 T Magnetic Resonance Systems…

Date posted by the FDA

Nov. 24, 2010

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.

Reason

Signa MR Excite" 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip along the phase encode direction and incorrect annotation, which may result in incorrect localization of anatomy in oblique axial images with the pulse sequences.

Distribution pattern

Worldwide Distribution: Throughout USA except states of AK, VT and WY, and the countries of: Argentina, Australia, Bulgaria, Brazil, China, Canada, Switzerland, Chile, Colombia, Czech Republic, Ecuador, Egypt, Spain, Finland, France, Great Britain, Guatemala, Honduras, Croatia, Hungary, Indonesia, Ireland, India, Iran, Iceland, Italy, Japan, Kenya, South Korea, Kuwait, Lebanon, Luxembourg, Libya, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Puerto Rico, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Syria, Thailand, Tunisia, Turkey, Taiwan, Venezuela, and South Africa.

Quantity

1464

Codes and lots

SERIAL 00000241722MR8 00000260866MR9 00000249278MR3 00000260469MR2 00000249255MR1 00000261573MR0 00000238865MR0 00000242555MR1 00000262505MR1 00000252924MR6 00000258420MR9 00000261471MR7 00000254670MR3 00000273018MR2 00000254201MR7 00000252660MR6 00000249765MR9 00000259127MR9 00000260668MR9 00000268135MR1 00000252431MR2 00000254491MR4 00000267109MR7 00000255207MR3 00000236505MR4 00000254488MR0 00000270523MR4 00000249766MR7 00000241719MR4 00000257738MR5 00000259123MR8 00000270517MR6 00000264015MR9 00000250201MR1 00000256694MR1 00000287765MR2 00000261473MR3 00000267851MR4 00000237948MR5 00000270522MR6 00000265826MR8 00000247722MR2 00000249658MR6 00000249279MR1 00000255226MR3 00000243767MR1 00000235676MR4 00000243766MR3 00000252429MR6 00000248164MR6 00000249273MR4 00000257725MR2 00000243408MR2 00000262900MR4 00000250438MR9 00000257437MR4 00000255201MR6 00000251801MR7 00000268134MR4 00000261379MR2 00000254486MR4 00000249764MR2 00000255613MR2 00000238871MR8 00000284321MR7 00000233271MR6 00000250020MR5 00000265099MR2 00000260019MR5 00000242546MR0 00000247224MR9 00000243693MR9 00000276420MR7 00000258418MR3 00000230681MR9 00000243244MR1 00000258396MR1 00000246619MR1 00000251725MR8 00000249763MR4 00000252923MR8 00000249275MR9 00000272883MR0 00000233436MR5 00000235693MR9 00000237071MR6 00000237701MR8 00000238167MR1 00000239028MR4 00000239227MR2 00000239234MR8 00000241869MR7 00000242173MR3 00000250208MR6 00000252297MR7 00000254662MR0 00000255203MR2 00000255206MR5 00000255209MR9 00000258411MR8 00000259119MR6 00000261478MR2 00000262154MR8 00000262659MR6 00000263947MR4 00000264455MR7 00000273297MR2 00000273444MR0 00000281290MR7 00000291887MR8 00000241135MR3 00000268316MR7 00000272881MR4 00000274164MR3 00000249758MR4 00000239529MR1 00000271651MR2 00000271864MR1 00000280747MR7 00000291787MR0 00000255616MR5 00000237002MR1 00000259582MR5 00000267104MR8 00000250442MR1 00000271861MR7 00000288144MR9 00000259528MR8 00000251798MR5 00000237005MR4 00000251717MR5 00000270524MR2 00000252925MR3 00000262050MR8 00000262507MR7 00000240111MR5 00000247720MR6 00000259567MR6 00000236699MR5 00000243685MR5 00000270525MR9 00000232409MR3 00000259581MR7 00000238868MR4 00000253828MR8 00000271646MR2 00000253148MR1 00000262506MR9 00000263577MR9 00000241724MR4 00000290550MR3 00000250194MR8 00000287257MR0 00000239232MR2 00000273293MR1 00000245406MR4 00000256708MR9 00000231898MR8 00000256697MR4 00000257754MR2 00000233297MR1 00000232421MR8 00000234845MR6 00000283409MR1 00000237939MR4 00000236833MR0 00000253631MR6 00000248132MR3 00000251726MR6 00000251243MR2 00000262407MR0 00000262596MR0 00000253623MR3 00000267850MR6 00000239861MR8 00000264794MR9 00000245942MR8 00000250443MR9 00000237064MR1 00000231911MR9 00000281800MR3 00000237004MR7 00000262813MR9 00000238352MR9 00000243179MR9 00000233445MR6 00000234794MR6 00000237710MR9 00000280695MR8 00000285431MR3 00000259941MR3 00000238362MR8 00000291932MR2 00000272562MR0 00000236502MR1 00000239246MR2 00000241133MR8 00000261576MR3 00000261590MR4…

Recall started

May 11, 2009

Device type

System, Nuclear Magnetic Resonance Imaging

Root cause (FDA)

Software design

What the company told customers

GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 21, 2009. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Field Engineers will contact customers to schedule a field modification of the affected products to address this issue. Customers can contact GE Healthcare at 262 521-6100 about this issue.

Recall number

Z-0462-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0462-2011. The agency record governs; check it and the company before acting.