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U.S. Department of Health and Human Services

Class 1 Device Recall SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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  Class 1 Device Recall SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING see related information
Date Initiated by Firm January 07, 2015
Date Posting Updated February 18, 2015
Recall Status1 Terminated 3 on September 10, 2015
Recall Number Z-1035-2015
Recall Event ID 70209
510(K)Number K012200  K013636  K030874  K040444  K041476  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w.

Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.
Code Information 2, RADNETMR1501, 503251PMR2, 505243PMR, 503215MR2, SEMRI1, 317338MR2, 972596PMR2, 717843MR2, 208373MR, 612813MR1, 219533MR, 201456MR2, 904296LMR2, 845279MR, 914897MR, 817685MR1, 972562MMR1, 260373MR, 865588MR2, 717291MR, 501207MR2, MR6, INSIGHTMR1906, 913491MR, 831625MR, 916734PMR2, 417887MR1, 702228LXMR, ALLIANCESIG407, 573221HCMR, 305573MR2, 256SPCMR, 403259MR2, 651602MR2, 212305MR4, 662841MR2, 781340MR, 909825VAMRX, 414MD1711, 425697VCMR, 00000279812MR2 DK1066MR01, MODMR1, 00000000444M20 35023MRS01, 00000117760YM9 RU1046MR01, 00000169349YM8 RU1043MR01, 00000117779YM9 YU4006MR01, 0000095-0810-5 RU1003MR01, 00000117799YM7 RU1041MR01, 00000169347YM2 RU1144MR01, 000094-0810-10 M8572201, 000093-0427-15 DC3101, 414C5137, 414C3631, 00000117734YM4 270606, 00000117764YM1 0788-1, 00000169352YM2 UK1015MR01, 00000169357YM1 RU3138MR01, 0000092-0629-5 DC2066, 0000093-0329-5 DC3097, 0000093-0826-8 DC3110, 0000093-0914-1 DC3124, 0000094-1209-1 DC4176, 00000117789YM8 DC9991.
Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact local service representative
800-437-1171
Manufacturer Reason
for Recall
At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.
FDA Determined
Cause 2
Employee error
Action GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 60876 dated January 6, 2015 to affected consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. Customers were instructed to do the following: As a preventative measure, confirm that MRU is connected to the magnet by performing the following four step test on the MRU. 1. Verify the green CHARGER POWER LED is lit. 2. Depress and hold the TEST BATTERY switch for 15 seconds. The green BATTERY TEST LED should light and remain lit while the TEST BATTERY switch is depressed. 3. Place the TEST HEATER toggle switch in the A position. The green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. 4. Place the TEST HEATER toggle switch in the B position. Green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. If the MRU test does not perform as described in each of the 4 steps above, GEHC strongly recommends that you stop using the system, and immediately call your GEHC representative. Customers with questions may contact their local service representative. For questions regarding this recall call 1-800-437-1171.
Quantity in Commerce 12,968 (5,708 US, 7,260 OUS).
Distribution Worldwide Distribution - US Nationwide in all states in continental USA including DC, PR, GU, and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR,K ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE , UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, ZAMBIA.
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 MEDICAL SYSTEMS
510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC
510(K)s with Product Code = LNH and Original Applicant = GENERAL ELECTRIC CO.
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