• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Signa Excite 1.5 T (Excite II)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Signa Excite 1.5 T (Excite II) see related information
Date Posted February 24, 2011
Recall Status1 Terminated on July 03, 2012
Recall Number Z-1432-2011
Recall Event ID 57084
510(K)Number K013636 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product 9) Signa Excite 1.5 T (Excite II)
(K013636 Signa Infinity MR System with EXCITE Technology)

Signa Infinity MR System with EXCITE
(K013636 Signa Infinity MR System with EXCITE Technology)

The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Code Information 000288244MR7
00000286559MR0
00000290325MR0
00000285019MR6
00000290654MR3
00000169152MR6
00000234632MR8
00000236061MR8
00000239878MR2
00000249765MR9
00000249264MR3
00000257437MR4
00000254670MR3
00000254558MR0
00000261471MR7
00000267110MR5
00000237120MR1
00000270522MR6
00000262056MR5
00000246255MR4
00000270974MR9
00000272893MR9
00000278749MR7
00000277601MR1
00000280898MR8
00000280951MR5
00000285380MR2
00000283761MR5
00000286800MR8
00000289798MR1
00000011952YR9
000000HDMR5452
00000288811MR3
00000011866YR1
00000012358YR8
00000919BD5BA8
00000950BD62BD
00001007BD6491
00000213048MR2
00000212964MR1
00000214776MR7
00000258640MR2
00000294328MR0
00000293650MR8
00000202406MR5
00000212444MR4
00000210814MR0
00000241631MR1
00000235857MR0
00000243472MR8
00000245944MR4
00000252431MR2
00000249017MR5
00000252429MR6
00000255201MR6
00000026066MR9
00000262664MR6
00000267106MR3
00000270515MR0
00000270523MR4
00000259123MR8
00000273229MR5
00000273018MR2
00000264157MR9
00000274996MR8
00000256224MR7
00000282088MR4
00000284787MR9
00000285222MR6
000000HDMR5477
00000011928YR9
00000293298MR6
00000937BD5ED6
00000133741MR9
00000207841MR8
00000GE0131001
00000223631MR3
00000235861MR2
00000238872MR6
00000238516MR9
00000241158MR5
00000244613MR6
00000249766MR7
00000257738MR5
00000261442MR8
00000260625MR9
00000260866MR9
00000265590MR0
00000267851MR4
00000252920MR4
00000273676MR7
00000276635MR0
00000280005MR0
00000277190MR5
00000283378MR8
00000286538MR4
000000HDMR3637
000000HDMR3872
000000HDMR5356
00000011574YR1
00000011871YR1
00000012315YR8
00000294284MR5
00000012304YR2
000000HDMR6160
00000295529MR2
00000133739MR3
00000174695MR7
00000230879MR9
00000237557MR4
00000245808MR1
00000247722MR2
00000251801MR7
00000250509MR7
00000262900MR4
00000261327MR1
00000260078MR1
00000259127MR9
00000268134MR4
00000267107MR1
00000268321MR7
00000270517MR6
00000266801MR0
00000272894MR7
00000277583MR1
00000279802MR3
00000280621MR4
00000285303MR4
00000282831MR7
00000283174MR1
00000286897MR4
000000HDMR3086
000000HDMR6256
000000HDMR6030
00000243481MR9
00000242552MR8
00000257444MR0
00000254488MR0
00000256694MR1
00000255207MR3
00000264089MR4
00000274688MR1
00000277487MR5
00000284644MR2
00000131855MR9
00000202045MR1
00000225331MR8
00000235447MR0
00000244912MR2
00000250438MR9
00000257725MR2
00000260670MR5
00000260469MR2
00000261386MR7
00000258101MR5
00000261380MR0
00000265593MR4
00000264006MR8
00000273223MR8
00000275091MR7
00000271648MR8
00000275598MR1
00000277189MR7
00000279752MR0
00000280319MR5
00000276370MR4
00000252435MR3
000000HDMR5330
000000HDMR5474
00000011876YR0
00000012190YR5
00000848BD5311
00000288589MR5
00000939BD5F52
00000235099MR9
00000279458MR4
00000VALUE1280
00000245794MR3
00000198731MR2
00000255198MR4
00000255226MR3
00000199744MR4
00000217628MR7
00000223637MR0
00000219362MR1
00000265095MR0
00000264784MR0
00000267109MR7
00000VALUE1179
00000938BD5F17
00000215890MR5
00000226509MR8
00000233624MR6
00000280299MR9
00000281936MR5
00000284457MR9
00000180795MR7
00000213687MR7
00000213657MR0
00000248164MR6
00000268135MR1
00000267809MR2
00000282858MR0
00000261198MR6
00000285219MR2
00000283662MR5
00000012125YR1
00000912BD59B9
00000012270YR5
000000HDMR6153
00000939BD5F50
00000939BD5FAC
00000243674MR9
00000267650MR0
00000281317MR8
00000255251MR1
000000HDMR5783
00000913BD5A48
00000831BD49FE
00000919BD5BA1
00000180937MR5
00000247021MR9
00000257756MR7
00000254201MR7
00000273535MR5
00000287590MR4
00000264997MR8
00000278566MR5
00000249255MR1
00000262733MR9
00000261573MR0
00000280002MR7
000000HDMR5342
00001009BD655B
00000253190MR3
00000254666MR1
00000265091MR9
00000259574MR2
00000008560YR5
00000012352YR1
00000944BD6168
00000950BD6295
00000297014MR3
00000913BD5A4B
00000214778MR3
00000247774MR3
00000248335MR2
00000283076MR8
00000249279MR1
00000250827MR3
00
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patient safety. If the gradient cables are inadvertently swapped while servicing the gradients, and the Service Engineer does not perform the geometry check as required in the service procedure, images m
FDA Determined
Cause 2
Nonconforming Material/Component
Action On November 9, 2010, the firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated November 5, 2010 to all Consignees/Customers. The letter described the product, problem and action to be taken by the firm. GE instructed the customers to contact their local GEHC support Engineer, if they have any questions about the image orientation, or the procedures for geometry checks on thier system. Additionally, a GE Healthcare representative will install a device, which will reduce the potiential for the gradient cables to be swapped. Contact your local GEHC Support Engineer if you have any questions concerning this notification or phone: 262-548-2731.
Quantity in Commerce 1175
Distribution Worldwide distribution: USA including DC and PR; and countries including: VIET NAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, FORMER YUGOSLAV REPUBLIC OF MACEDONIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, REPUBLIC OF KOREA, PORTUGAL POLAND, PHILIPPINES, PERU,PARAGUAY, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MAURITIUS, MARTINIQUE,MALTA, MALAYSIA, LUXEMBOURG,LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, KENYA, KAZAKHSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUYANA, GUATEMALA, GUADELOUPE, GREECE, GERMANY, GEORGIA, FRENCH POLYNESIA, FRANCE, FINLAND, EL SALVADOR, EGYPT, ECUADOR, DOMINICAN REPUBLIC, DENMARK, CECH REPUBLIC, CYPRUS, CROATIA, COLOMBIA, CHINA, CHILE, CANDA, BULGARIA, BRAZIL, BOSNIA AND HERZEGOVINA, BOLIVIA, BELGIUM, BELARUS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS
-
-