FDA · Medical device recall

1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System… and 9 more products

Feb. 24, 2011

Date posted by the FDA: Feb. 24, 2011
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: 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
Distribution pattern: 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…

10 products in this recall

1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic…

Product: 1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of the internal structures of the head or body. The images produced by the signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Quantity: 3105
Codes and lots: SERIAL 00000232068MR7 00000200618MR7 00000253500MR3 00000161854MR5 00000161128MR4 00000212453MR5 00000205557MR2 00000194277MR0 00000210629MR2 00000210789MR4 00000202408MR1 00000241094MR2 00000227605MR3 00000157686MR7 00000215316MR1 00000180421MR0 00000215313MR8 00000180899MR7 00000143624MR5 00000180897MR1 00000112550MR9 00000115704MR9 00000193709MR3 00000119503MR1 00000194626MR8 00000112027MR8 00000216508MR2 00000228081MR6 00000125783MR1 00000172839MR3 00000169151MR8 00000132803MR8 00000127413MR3 00000170580MR5 00000186751MR4 4351 00000235440MR5 00000170568MR0 00000220886MR6 00000198717MR1 00000156808MR8 00000205961MR6 00000226212MR9 00000241637MR8 00000155840MR2 00000181846MR7 00000217037MR1 00000148024MR3 00000226765MR6 00000159686MR5 00000222678MR5 00000178826MR4 00000183398MR7 00000218457MR0 00000159580MR0 00000164251MR1 00000235742MR4 00000170910MR4 00000121825MR4 00000239201MR7 00000165426MR8 00000124330MR2 00000231220MR5 00000123369MR1 00000208845MR8 00000166125MR5 00000142605MR5 00000215887MR1 00000199112MR4 00000167817MR6 00000151839MR8 00000180083MR8 00000154237MR2 00000232234MR5 00000223690MR9 00000224283MR2 00000214786MR6 00000214332MR9 00000221502MR8 00000238337MR0 00000235093MR2 00000151024MR7 00000126178MR3 00000168284MR8 00000212445MR1 00000233208MR8 00000162577MR1 00000214307MR1 00000137614MR4 00000233406MR8 00000172733MR8 00000116883MR0 00000108299MR9 00000166734MR4 00000194640MR9 00000200456MR2 00000235445MR4 4563 00000194635MR9 00000134508MR1 00000258182MR5 00000225022MR3 00000179498MR1 00000222291MR7 00000195819MR8 00000233015MR7 00000122281MR9 00000175057MR9 00000172833MR6 00000151957MR8 00000111157MR4 00000153576MR4 00000201909MR9 00000118962MR0 00000113891MR6 00000173562MR0 00000122780MR0 00000104691MR1 00000148234MR8 00000110539MR4 00000169157MR5 00000162596MR1 00000220883MR3 00000188412MR1 00000151995MR8 00000158407MR7 00000149036MR6 00000208841MR7 00000223493MR8 00000250829MR9 00000126170MR0 00000214783MR3 00000178814MR0 00000198053MR1 00000198726MR2 00000195806MR5 00000123365MR9 00000117426MR7 00000165790MR7 00000165893MR9 00000231850MR9 00000228263MR0 00000122352MR8 00000186754MR8 00000165431MR8 00000208812MR8 00000180436MR8 00002242271MR7 00000166444MR0 00000227939MR6 00000154876MR7 00000225881MR2 00000199734MR5 00000205542MR4 00000121256MR2 00000174692MR4 00000104728MR1 00000202048MR5 00000228542MR7 00000183397MR9 00000161850MR3 00000238787MR6 00000242501MR5 00000171554MR9 00000234778MR9 00000199096MR9 00000180905MR2 00000231332MR8 00000242819MR1 00000175034MR8 00000139719MR9 00000203407MR2 00000241159MR3 00000210640MR9 00000230634MR8 00000236233MR3 00000234874MR6 00000214768MR4 00000129567MR4 00000225341MR7 00000264785MR7 00000221898MR0 00000137858MR7 00000143615MR3 00000232057MR0 00000214355MR0 00000198054MR9 00000180086MR1 00000241160MR1 00000191917MR4 00000213656MR2 00000248919MR3 00000121831MR2 00000235094MR0 00000140903MR6 00000235722MR6 00000186261MR4 00000218181MR6 00000209588MR3 00000168170MR9…
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1424-2011

2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is…

Product: 2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
Quantity: 1
Codes and lots: SERIAL 00000089479MR0
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1425-2011

3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is intended for…

Product: 3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
Quantity: 61
Codes and lots: SERIAL 00000074474MR8 00000071647MR2 00000064133MR2 00000093648MR4 00000059436MR6 00000075228MR7 00000088102MR9 00000060654MR1 00000092075MR1 00000093923MR1 00000074470MR6 00000100268MR2 00000073606MR6 00000073263MR6 00000075508MR2 00000088586MR3 00000057884MR9 00000060062MR7 00000069374MR7 00000060657MR4 00000061256MR4 00000067843MR3 00000100259MR1 00000102085MR8 00000066295MR7 00000092067MR8 00000100257MR5 00000089478MR2 00000095838MR9 00000066840MR0 00000087273MR9 00000078709MR3 00000075989MR4 00000095460MR2 00000080468MR2 00000095845MR4 00000076713MR7 00000077976MR9 00000078328MR2 00000076710MR3 00000072290MR0 00000076426MR6 00000105672MR0 00000077457MR0 00000082972MR1 00000080470MR8 00000102592MR3 00000066844MR2 00000074134MR8 00000073605MR8 00000098416MR1 00000103956MR9 00000095047MR7 00000092079MR3 00000082250MR2 00000088106MR0 00000055001MR2 00000088108MR6 00000088574MR9 00000082246MR0 00000070159MR9
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1426-2011

4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole body magnetic…

Product: 4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, 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 HDe system 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.
Quantity: 643
Codes and lots: SERIAL 00000006175YR4 00000006195YR2 00000008700YR7 00000008722YR1 00000008724YR7 00000010581YR7 00000011496YR7 00000011668YR1 00000012101YR2 00000012145YR9 00000012146YR7 00000012149YR1 00000012792YR8 00000013308YR2 00000011532YR9 00000005068YR2 00000006514YR4 00000006515YR1 00000006516YR9 00000006519YR3 00000006522YR7 00000006525YR0 00000006528YR4 00000006532YR6 00000006535YR9 00000006538YR3 00000006544YR1 00000012221YR8 00000005079YR9 00000005080YR7 00000005081YR5 00000005648YR1 00000005656YR4 00000005659YR8 00000005664YR8 00000006155YR6 00000006157YR2 00000006172YR1 00000006176YR2 00000006177YR0 00000006188YR7 00000006194YR5 00000006198YR6 00000006200YR0 00000006204YR2 00000007947YR5 00000007954YR1 00000007969YR9 00000007970YR7 00000007971YR5 00000008692YR6 00000008697YR5 00000008698YR3 00000008699YR1 00000008701YR5 00000008703YR1 00000008709YR8 00000008715YR5 00000008716YR3 00000008720YR5 00000008726YR2 00000008727YR0 00000008728YR8 00000008729YR6 00000008732YR0 00000008734YR6 00000009833YR5 00000010024YR8 00000010025YR5 00000010114YR7 00000010578YR3 00000010583YR3 00000010686YR4 00000010794YR6 00000010795YR3 00000010830YR8 00000010831YR6 00000010834YR0 00000010856YR3 00000010863YR9 00000011210YR2 00000011428YR0 00000011429YR8 00000011495YR9 00000011499YR1 00000011637YR6 00000011648YR3 00000011650YR9 00000011669YR9 00000011686YR3 00000011826YR5 00000011829YR9 00000011830YR7 00000011842YR2 00000012085YR7 00000012098YR0 00000012099YR8 00000012100YR4 00000012102YR0 00000012142YR6 00000012172YR3 00000012206YR9 00000012207YR7 00000012227YR5 00000012286YR1 00000012287YR9 00000012289YR5 00000012330YR7 00000012393YR5 00000012434YR7 00000012435YR4 00000012503YR9 00000012507YR0 00000012576YR5 00000012651YR6 00000012652YR4 00000012727YR4 00000012728YR2 00000012755YR5 00000012756YR3 00000012818YR1 00000012820YR7 00000012940YR3 00000012943YR7 00000012988YR2 00000012992YR4 00000012994YR0 00000012995YR7 00000013056YR7 00000013061YR7 00000013177YR1 00000013180YR5 00000013185YR4 00000013239YR9 00000013241YR5 00000013246YR4 00000013301YR7 00000013306YR6 00000013310YR8 00000013375YR1 00000013379YR3 00000013384YR3 00000013385YR0 00000013399YR1 00000013453YR6 00000013799YR2 00000013800YR8 00000013802YR4 00000013804YR0 00000004984YR1 00000011536YR0 00000012290YR3 00000006199YR4 00000010115YR4 00000005072YR4 00000005074YR0 00000006510YR2 00000006511YR0 00000006523YR5 00000006530YR0 00000006533YR4 00000006534YR2 00000006541YR7 00000006542YR5 00000006543YR3 00000006553YR2 00000006554YR0 00000006203YR4 00000010939YR7 00000010976YR9 00000012552YR6 00000012553YR4 00000012574YR0 00000012793YR6 00000012794YR4 00000012878YR5 00000012996YR5 00000013058YR3 00000013059YR1 00000013378YR5 00000013629YR1 00000013204YR3 00000013757YR0 00000013380YR1 00000010252YR5 00000012797YR7 00000012328YR1 00000012990YR8 00000013450YR2 00000012083YR2 00000013179YR7 00000010229YR3 00000006521YR9 00000006545YR8 00000006550YR8 00000005082YR3 00000006196YR0 00000010230YR1 00000012823YR1…
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1427-2011

5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR…

Product: 5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, 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 HDe system 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.
Quantity: 2417
Codes and lots: SERIAL 000000HDMR3855 00000290191MR6 21 000000HDMR5594 000000HDMR3972 000000HDMR5909 00000HDMR10275 000000HDMR4367 000000HDMR2622 1568421 00000288797MR4 000000HDMR2901 000000HDMR2799 00000011875YR2 00000289023MR4 000000HDMR4087 000000HDMR5809 000000HDMR6277 00000HDMR27758 000000HDMR5774 000000HDMR3407 00000DDDM10670 000000HDMR3649 00000289786MR6 000000HDMR3464 00000GE0743594 00000HDMR20044 00000HDMR20171 000000HDMR5401 000000HDMR3861 000000HDMR1063 000000HDMR3724 00000011927YR1 00000280253MR6 00000HDMR10554 000000HDMR4015 00000HDMR10788 00000HDMR20157 000000HDMR3261 00000HDMR10459 000000HDMR3470 000000HDMR3330 000000HDMR2936 00000011926YR3 00000HDMR20298 000000HDMR3010 000000HDMR5633 000000HDMR2377 000000HDMR3008 000000HDMR3391 000000HDMR5224 000000HDMR2924 000000HDMR6012 000000HDMR3844 00000HDML10300 000000HDMR3679 00000011571YR7 000000HDMR5228 00000012239YR0 000000HDMR2531 00000012078YR2 000000HDMR1148 00000011867YR9 00000011595YR6 000000HDMR3885 000000HDMR2962 000000HDMR4242 000000HDMR3150 00000280251MR0 000000HDMR3141 00000011786YR1 00000011887YR7 000000HDMR4062 000000HDMR6263 000000HDMR3152 000000HDMR3811 00000HDMR20219 00000HDMR20258 00000HDMR10630 00000012241YR6 000000HDMR5593 00000278041MR9 000000HDMR3514 000000HDMR5765 000000HDMR3513 000000HDMR5956 000000HDMR2590 000000HDMR2892 00000HDMR20018 00000HDMR10743 00000HDMR11028 000000HDMR2967 00000011746YR5 000000HDMR6031 00000277916MR3 000000HDMR4299 000000HDMR3987 00000HDMR20256 00000012180YR6 00000011586YR5 000000HDMR6029 000000HDMR6292 00000011878YR6 000000HDMR3529 000000HDMR3142 000000HDMR2508 00000011502YR2 000000HDMR4149 000000HDMR4106 00000HDMR20142 00000011742YR4 00000HDMR20050 000000HDMR4154 00000011588YR1 000000HDMR5584 000000HDMR5844 000000HDMR4081 000000HDMR3648 00000012042YR8 000000HDMR3329 000000HDMR3248 000000HDMR3755 000000HDMR3766 000000HDMR3979 000000HDMR3633 00000HDMR20151 000000HDMR4204 000000HDMR3916 000000HDMR3262 00000011798YR6 000000HDMR3810 000000HDMR5525 000000HDMR2515 00000012163YR2 000000HDMR2653 00000275647MR6 000000HDMR2615 00000011579YR0 000000HDMR3732 00000011596YR4 000000HDMR2641 000000HDMR4293 000000HDMR5605 000000HDMR5442 000000HDMR6311 000000HDMR3681 000000HDMR6297 00000HDMR10722 000000HDMR3543 000000HDMR2852 000000HDMR3099 000000HDMR2998 000000HDMR2328 000000HDMR5941 000000HDMR3108 000000HDMR3190 00000HDMR20276 00000HDMR20065 00000HDMR20053 000000HDMR6080 00000HDMR10944 00000HDMR10622 000000HDMR3909 000000HDMR5486 000000HDMR2451 000000HDMR4021 000000HDMR5949 000000HDMR5846 000000HDMR2463 000000HDMR4379 000000HDMR5532 000000HDMR2691 000000HDMR2556 000000HDMR3243 00000011938YR8 00000012196YR2 000000HDMR2399 00000286785MR1 000000HDMR4064 000000HDMR2588 000000HDMR3777 1516299 00000HDMR10891 000000HDMR2482 00000012050YR1 000000HDMR2741 00000012008YR9 00000012229YR1 000000HDMR2562 000000HDMR4040 157024 00000HDMR20070 000000HDMR3273 000000HDMR3401 000000HDMR3823 000000HDMR2949 00000HDMR20214 000000HDMR5855 00000011774YR7 000000HDMR1151 11797 00000277534MR4…
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1428-2011

6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite…

Product: 6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, 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 HDe system 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.
Quantity: 1219
Codes and lots: SERIAL 00000277692MR0 00000276632MR7 00000280465MR6 00000284315MR9 00000276732MR5 00000280892MR1 00000280464MR9 00000281796MR3 00000278623MR4 00000278196MR1 00000275595MR7 00000281935MR7 00000278626MR7 00000282909MR1 00000280461MR5 00000283074MR3 00000274891MR1 00000279922MR9 00000282548MR7 00000281267MR5 00000273517MR3 00000281020MR8 00000280954MR9 00000282105MR6 00000283998MR3 00000285302MR6 00000281346MR7 00000279502MR9 00000285599MR7 00000273536MR3 00000281185MR9 00000281312MR9 00000281456MR4 00000283663MR3 00000273487MR9 00000280009MR2 00000282253MR4 00000280276MR7 00000279925MR2 00000279887MR4 00000278472MR6 00000281445MR7 00000276633MR5 00000283316MR8 00000276728MR3 00000282695MR6 2284300 00000273537MR1 00000283452MR1 00000283468MR7 00000273265MR9 00000283345MR7 00000284360MR5 00000287579MR7 00000278245MR6 00000279503MR7 00000279078MR0 00000280435MR9 00000282830MR9 00000283077MR6 00000283653MR4 00000283437MR2 00000281681MR7 00000278622MR6 00000280620MR6 00000274711MR1 00000281022MR4 00000274713MR7 00000281314MR5 00000281273MR3 00000280274MR2 00000283665MR8 00000279915MR3 00000283365MR5 00000277599MR7 00000281265MR9 00000027862MR0 00000283530MR4 00000273541MR3 00000284786MR1 00000275937MR1 00000274937MR2 00000287317MR2 00000283624MR5 00000282788MR9 00000273516MR5 00000277763MR9 00000278726MR5 00000281227MR9 00000277965MR0 00000280094MR4 00000281347MR5 00000276330MR8 00000283377MR0 00000279076MR4 00000274717MR8 00002181458MR0 00000276735MR8 00000274931MR5 00000274170MR0 00000282463MR9 00000286406MR4 00000282524MR8 00000277788MR6 00000281937MR3 00000027888MR3 00000287864MR3 00000277959MR3 00000283151MR9 00000280278MR3 00000279627MR4 00000283473MR7 00000274930MR7 00000278619MR2 00000278246MR4 00000277700MR1 00000274889MR5 00000274933MR1 00000282849MR9 00000283471MR1 00000273514MR0 00000276737MR4 00000278561MR6 00000274939MR8 00000287086MR3 00000282812MR7 00000282492MR8 00000281457MR2 00000284903MR2 00000281526MR4 00000285664MR9 00000281776MR5 00000281703MR9 00000281188MR3 00000280374MR0 00000286309MR0 00000280462MR3 00000281442MR4 00000275597MR3 00000281829MR2 00000274709MR5 00000275474MR5 00000287063MR2 00000282792MR1 00000287617MR5 00000280069MR6 00000286391MR8 00000282107MR2 00000282106MR4 00000281644MR5 00000285951MR0 00000275936MR3 00000281678MR3 00000275938MR9 00000289205MR7 00000282857MR2 00000283506MR4 00000280767MR5 00000286526MR9 00000280095MR1 00000282961MR2 00000281266MR7 00000286425MR4 00000273008MR3 00000281840MR9 00000283435MR6 00000280434MR2 00000279080MR6 00000280526MR5 00000282080MR1 00000286282MR9 00000283317MR6 00000279892MR4 00000286476MR7 00000280903MR6 00000283357MR2 00000283385MR3 00000285384MR4 00000287396MR6 00000274892MR9 00000283696MR3 00000285023MR8 00000286267MR0 00000283474MR5 00000282911MR7 00000284214MR4 00000275475MR2 00000286149MR0 00000275736MR7 00000283697MR1 00000277600MR3 00000289162MR0 00000286250MR6 00000280619MR8 00000281056MR2 00000280713MR9 00000280759MR2 00000281313MR7 00000275473MR7 00000281865MR6…
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1429-2011

7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with…

Product: 7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Due to the open design of the system, the Signa 0.7T Signa OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles. . .
Quantity: 176
Codes and lots: SERIAL 00000003028YR8 00000003035YR3 00000000144YR6 00000003033YR8 00000003042YR9 00000000155YR2 00000000111YR5 00000000146YR1 00000003024YR7 00000000103YR2 00000003011YR4 00000000142YR0 00000003043YR7 00000003034YR6 00000000153YR7 00000000151YR1 00000003025YR4 00000003029YR6 00000000149YR5 00000003030YR4 00000003023YR9 00000003044YR5 00000003036YR1 00000000102YR4 00000000133YR9 00000003027YR0 00000003041YR1 00000003022YR1 00000003031YR2 00000000127YR1 00000003026YR2 00000003039YR5 00000003050YR2 00000003051YR0 00000000132YR1 00000000109YR9 00000000120YR6 00000000100YR8 00000000108YR1 00000962592YM2 00000000118YR0 00000951021YM5 00000000106YR5 00000000110YR7 00000000131YR3 00000000128YR9 00000000101YR6 00000000150YR3 00000000136YR2 00000000129YR7 00000000119YR8 00000000105YR7 00000943610YM6 00000000134YR7 00000000113YR1 00000000152YR9 00000000135YR4 00000253103MR6 00000243405MR8 00000237052MR6 00000241694MR9 00000230312MR1 00000217198MR1 00000241695MR6 00000228023MR8 00000253104MR4 00000221250MR4 00000217201MR3 00000232328MR5 00000204837MR9 00000216409MR3 00000226319MR2 00000237051MR8 00000230309MR7 00000207493MR8 00000250185MR6 00000201901MR6 00000237928MR7 00000234832MR4 00000250184MR9 00000226318MR4 00000207494MR6 00000247256MR1 00000228024MR6 00000208209MR7 00000203386MR8 00000231590MR1 00000194219MR2 00000234834MR0 00000222950MR8 00000239846MR9 00000215365MR8 00000253039MR2 00000216405MR1 00000237053MR4 00000196364MR4 00000194950MR2 00000189633MR1 00000208210MR5 00000244231MR7 00000247254MR6 00000229302MR5 00000241692MR3 00000229303MR3 00000241693MR1 00000237926MR1 00000247255MR3 00000247253MR8 00000202223MR4 00000225941MR4 00000231588MR5 00000212515MR1 00000206438MR4 00000192104MR8 00000201710MR1 00000217199MR9 00000209713MR7 00002397929MR5 00000237930MR3 00000241126MR2 00000233646MR9 00000239845MR1 00000230308MR9 00000197334MR6 00000221253MR8 00000237927MR9 00000208211MR3 00000225273MR2 00000212511MR0 00000234833MR2 00000225274MR0 00000228022MR0 00000225942MR2 00000239483MR1 00000231592MR7 00000217202MR1 00000233644MR4 00000212513MR6 00000232329MR3 00000239480MR7 00000209712MR9 00000229306MR6 00000215364MR1 00000244232MR5 00000221251MR2 00000216406MR9 00000250187MR2 00000241127MR0 00000221254MR6 00000212514MR4 00000204839MR5 00000201709MR3 00000208208MR9 00000239847MR7 00000239484MR9 00000194218MR4 00000193652MR5 00000239482MR3 00000229304MR1 00000229305MR8 00000003047YR8 00000231589MR3 00000231591MR9 00000250186MR4 00000247252MR0 00000000122YR2 00000216407MR7 00000228773MR8 00000000124YR8 00000000137YR0 00000201708MR5 00000199443MR3 00000003049YR4 00000253102MR8 00000204838MR7 00000198709MR8
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1430-2011

8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa…

Product: 8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) 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.
Quantity: 73
Codes and lots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
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1431-2011

9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR…

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.
Quantity: 1175
Codes and lots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…
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1432-2011

10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US…

Product: 10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330) The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/ Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Quantity: 67
Codes and lots: SERIAL 261733HM0 248583HM7 257798HM9 257789HM8 245748HM9 242138HM6 250054HM4 252380HM1 242952HM0 242143HM6 250048HM6 249456HM5 245624HM2 256141HM3 245745HM5 250042HM9 250459HM5 252396HM7 250057HM7 250039HM5 252399HM1 252405HM6 250045HM2 257546HM2 250051HM0 252402HM3 250462HM9 252422HM1 252408HM0 252417HM1 257777HM3 259660HM9 256156HM1 256433HM4 256424HM3 256153HM8 259657HM5 256150HM4 250465HM2 257768HM2 256144HM7 256427HM6 252414HM8 252393HM4 261005HM3 252375HM1 262286HM8 257771HM6 256147HM0 257780HM7 257783HM1 259648HM4 256455HM7 256448HM2 261730HM6 261011HM1 257792HM2 256430HM0 257549HM6 257774HM0 257543HM9 259663HM3 257786HM4 259651HM8 259654HM2 261008HM7 259666HM6
Recall started: Nov. 9, 2010
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-1433-2011

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1424-2011, Z-1425-2011, Z-1426-2011, Z-1427-2011, Z-1428-2011, Z-1429-2011, Z-1430-2011, Z-1431-2011 and others. The agency record governs; check it and the company before acting.

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