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U.S. Department of Health and Human Services

Class 2 Device Recall Signa 3.0T Infinity with EXCITE

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 Class 2 Device Recall Signa 3.0T Infinity with EXCITE see related information
Date Posted February 24, 2011
Recall Status1 Terminated on July 03, 2012
Recall Number Z-1431-2011
Recall Event ID 57084
510(K)Number K030874 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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.

Code Information SERIAL
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00000GE0302069
00000GE0208031
00000GE0150023
00000GE0318071
00000GE0210034
00000GE0144007
00000GE0123041
00000GE0239059
00000GE0234057
249065
00000GE0302068
00000GE0444111
00000GE0245061
00000GE0212037
00000GE0210033
00000GE0351031
00000GE0151026
00000GE0209032
00000GE0417056
00000GE0441101
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00000GE0246063
00000GE0236056
00000GE0326073
00GE03450026GG
00000GE0232053
00000GE0213040
00000GE0205028
00000GE0206027
00000GE0205029
00000GE0131001
00000GE0245062
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00000262737MR0
00000251090MR7
00000265828MR4
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00000256197MR5
00000252442MR9
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00000227450MR7
00000261070MR7
00000249271MR8
00000256199MR1
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00000261332MR1
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
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 73
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 = GENERAL ELECTRIC CO.
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