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U.S. Department of Health and Human Services

Class 2 Device Recall Signa OpenSpeed

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 Class 2 Device Recall Signa OpenSpeed see related information
Date Posted February 24, 2011
Recall Status1 Terminated on July 03, 2012
Recall Number Z-1430-2011
Recall Event ID 57084
510(K)Number K032795 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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. . .

Code Information SERIAL
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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 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 176
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, LLC
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