Class 2 Device Recall Signa Lx

• Date Initiated by Firm: November 09, 2010
• Date Posted: February 24, 2011
• Recall Status: Terminated on July 03, 2012
• Recall Number: Z-1424-2011
• Recall Event ID: 57084
• 510(K)Number: K962061
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• 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.
• Code Information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• 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: 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: 3105
• 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS