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U.S. Department of Health and Human Services

Class 2 Device Recall Signa OpenSpeed

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 Class 2 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
Premarket Notification
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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
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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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