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U.S. Department of Health and Human Services

Class 2 Device Recall Signa Advantage

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 Class 2 Device Recall Signa Advantage see related information
Date Posted February 24, 2011
Recall Status1 Terminated on July 03, 2012
Recall Number Z-1426-2011
Recall Event ID 57084
510(K)Number K911959 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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).

Code Information 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
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 61
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
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