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U.S. Department of Health and Human Services

Class 2 Device Recall Brivo MR355/Optima MR360

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  Class 2 Device Recall Brivo MR355/Optima MR360 see related information
Date Initiated by Firm November 09, 2010
Date Posting Updated February 24, 2011
Recall Status1 Terminated 3 on July 03, 2012
Recall Number Z-1433-2011
Recall Event ID 57084
510(K)Number K103330  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product 10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330)

The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/ Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Code Information SERIAL , 261733HM0, 248583HM7, 257798HM9, 257789HM8, 245748HM9, 242138HM6, 250054HM4, 252380HM1, 242952HM0, 242143HM6, 250048HM6, 249456HM5, 245624HM2, 256141HM3, 245745HM5, 250042HM9, 250459HM5, 252396HM7, 250057HM7, 250039HM5, 252399HM1, 252405HM6, 250045HM2, 257546HM2, 250051HM0, 252402HM3, 250462HM9, 252422HM1, 252408HM0, 252417HM1, 257777HM3, 259660HM9, 256156HM1, 256433HM4, 256424HM3, 256153HM8, 259657HM5, 256150HM4, 250465HM2, 257768HM2, 256144HM7, 256427HM6, 252414HM8, 252393HM4, 261005HM3, 252375HM1, 262286HM8, 257771HM6, 256147HM0, 257780HM7, 257783HM1, 259648HM4, 256455HM7, 256448HM2, 261730HM6, 261011HM1, 257792HM2, 256430HM0, 257549HM6, 257774HM0, 257543HM9, 259663HM3, 257786HM4, 259651HM8, 259654HM2, 261008HM7, 259666HM6.
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 67
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 HANGWEI MEDICAL SYSTEMS CO., LTD.
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