—#97401

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.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K030874
Affected lot / code info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

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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, BOSNIA AND HERZEGOVINA, BOLIVIA, BELGIUM, BELARUS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.

Timeline

Recall initiated: 2010-11-09
Posted by FDA: 2011-02-24
Terminated: 2012-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97401. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.