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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 Posted February 24, 2011
Recall Status1 Terminated 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 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 HANGWEI MEDICAL SYSTEMS CO., LTD.
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