FDA · Medical device recall

GE 1.5T and 3.0T Signa HDx MR System The product is used as a… and 1 more product

Sept. 17, 2008

Date posted by the FDA: Sept. 17, 2008
Status: Terminated
Filed by: GE Healthcare
Reason: GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
Distribution pattern: AL, CA, CO,CT, AZ, FL, GA, LA, MS, MT, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NY, NV, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PUERTO RICO. AUSTRALIA, CHINA, HONG KONG, INDIA, JAPAN, SOUTH KOREA, NEW ZEALAND, TAIWAN, SWITZERLAND, GERMANY, DENMARK, SPAIN, FRANCE, GREAT BRITAIN, IRELAND, IRAN, ITALY, KUWAIT, LEBANON, NETHERLANDS, NORWAY, RUSSIA, SAUDI ARABIA, TURKEY, SOUTH AFRICA, BRAZIL, CANADA, and MEXICO.

2 products in this recall

GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial…

Product: GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body.
Quantity: 122
Codes and lots: Model 5127452: 00000HDMR20228 00000276057MR7 00000275160MR0 000000HDMR2544 00000HDMR10417 00000HDMR10094 00000274383MR9 00000273832MR6 00000274385MR4 00000276073MR4 00000274359MR9 00000HDMR10273 00000273119MR8 00000DDDM10670 00000HDMR20073 00000HDMR10739 000000HDMR2451 000000HDMR2335 00000HDMR20189 000000HDMR1004 00000HDMR10489 00000HDMR10291 00000HDMR20151 00000HDMR20061 00000HDMR10743 000000HDMR2528 000000HDMR2976 00000HDMR20044 000000HDMR2773 00000HDMR20294 00000HDMR20059 00000HDMR10418 00000HDMR10831 00000HDMR20036 and 00000HDMR20056 Model 2377062-61 00000008376YR6 00000007126YR6 00000007551YR5 00000007555YR6 00000006690YR2 00000007518YR4 00000008525YR8 00000005222YR5 00000007134YR0 00000008354YR3 00000005989YR9 00000007107YR6 00000008100YR0 00000007594YR5 00000006710YR8 00000008103YR4 00000007092YR0 00000007503YR6 00000007574YR7 00000006754YR6 00000007542YR4 00000008116YR6 00000008522YR5 00000006685YR2 00000007105YR0 00000008564YR7 00000005974YR1 00000005545YR9 00000006705YR8 00000006600YR1 00000007585YR3 00000005532YR7 00000008549YR8 00000007533YR3 00000007498YR9 00000005231YR6 00000006583YR9 00000005216YR7 00000007554YR9 00000009031YR6 00000006708YR2 00000007117YR5 00000007864YR2 00000007866YR7 00000007514YR3 00000008342YR8 00000005546YR7 00000007892YR3 00000007865YR9 00000006556YR5 00000006660YR5 00000007862YR6 00000009421YR9 00000007556YR4 00000008378YR2 00000008539YR9 00000006656YR3 00000005536YR8 00000008115YR8 00000008335YR2 00000052299YR0 00000006727YR2 00000006726YR4 and 00000007572YR1 Model 2395001-2 00000280673MR5 00000278397MR5 00000277211MR9 00000276434MR8 00000275968MR6 00000278549MR1 00000280781MR6 00000276265MR6 00000275046MR1 00000283745MR8 00000284233MR4 00000275648MR4 00000280000MR1 00000279068MR1 00000275967MR8 00000274744MR2 00000276266MR4 00000280001MR9 00000278851MR1 00000275647MR6 00000281340MR0 00000275465MR3 and 00000282549MR5
Recall started: Dec. 14, 2007
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: Consignees were sent a "GE Healthcare Product Safety Notification" letter dated 9/14/07. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the safety issue, affected product, safety instructions, product correction and contact information. FMI 60745 and 60746 was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. For assistance, contact GE Healthcare at 1-262-544-3894.
Recall number: Z-1890-2008

GE Signa Excite 1.5T MR System…

Product: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body.
Quantity: 147
Codes and lots: Model : 5107849 00000262460MR9 00000270245MR4 00000260692MR9 00000269581MR5 00000268123MR7 00000277574MR0 00000267973MR6 00000280302MR1 00000262803MR0 00000270974MR9 00000273229MR5 00000277190MR5 00000277189MR7 00000279752MR0 00000261198MR6 00000272433MR4 00000269437MR0 00000265177MR6 00000264407MR8 00000265173MR5 00000274998MR4 00000268011MR4 00000270383MR3 00000262459MR1 00000269326MR5 00000261064MR0 00000271248MR7 00000263970MR6 00000276409MR0 00000274835MR8 00000278722MR4 00000271120MR8 00000262456MR7 00000273459MR8 00000266821MR8 00000266071MR0 00000276491MR8 00000266066MR0 00000265061MR2 00000266754MR1 00000271234MR7 00000266343MR3 00000273365MR7 00000262299MR1 00000263879MR9 00000262793MR3 00000273341MR8 00000266822MR6 00000269340MR6 00000273230MR3 00000262800MR6 00000261678MR7 00000271246MR1 00000280388MR0 00000261205MR9 00000262666MR1 00000262673MR7 00000260480MR9 00000276591MR5 00000279460MR0 00000272533MR1 00000263974MR8 00000262667MR9 00000261066MR5 00000271124MR0 00000277955MR1 2333 00000272072MR0 00000261069MR9 00000264087MR6 00000267322MR6 00000274839MR0 00000265005MR9 00000275642MR7 00000270466MR6 00000275086MR7 00000261061MR6 00000275845MR6 00000272076MR1 00000269435MR4 00000270387MR4 00000268518MR8 00000268477MR7 00000268515MR4 00000269575MR7 00000272968MR9 00000270026MR8 00000272969MR7 00000272070MR4 00000268692MR1 00000271662MR9 00000268417MR3 00000270467MR4 00000272536MR4 00000273529MR8 00000279146MR5 00000275668MR2 and 00000260651MR5 Model 5107849-2: 00000279077MR2 00000282686MR5 00000283386MR1 00000283076MR8 00000279423MR8 00000278623MR4 00000278626MR7 00000279921MR1 00000276633MR5 00000273541MR3 00000274170MR0 00000274930MR7 00000281703MR9 00000281443MR2 00000281019MR0 00000275936MR3 00000279713MR2 00000273267MR5 and 00000273266MR7 Model: M3000PT: 00000266842MR4 00000266160MR1 00000271322MR0 00000275009MR9 00000268302MR7 00000263655MR3 00000264783MR2 00000266194MR0 00000267528MR8 00000026005MR8 00000266156MR9 00000265852MR4 00000267533MR8 000267533MR8ZZ 00000265968MR8 00000267529MR6 00000267527MR0 00000266690MR7 00000264643MR8 00000267618MR7 00000268837MR2 00000270528MR3 00000270097MR9 00000268301MR9 00000269332MR3 and 00000267860MR5 Model: M3000PW: 00000266270MR8 00000250462MR9 and 00000263921MR9
Recall started: Dec. 14, 2007
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: Consignees were sent a "GE Healthcare Product Safety Notification" letter dated 9/14/07. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the safety issue, affected product, safety instructions, product correction and contact information. FMI 60745 and 60746 was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. For assistance, contact GE Healthcare at 1-262-544-3894.
Recall number: Z-1891-2008

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1890-2008, Z-1891-2008. The agency record governs; check it and the company before acting.

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