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U.S. Department of Health and Human Services

Class 2 Device Recall GE Signa OpenSpeed 0.7T MR System

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 Class 2 Recall
GE Signa OpenSpeed 0.7T MR System
see related information
Date Posted June 30, 2009
Recall Status1 Open
Recall Number Z-1557-2009
Recall Event ID 52015
Premarket Notification
510(K) Numbers
K032795  K053009 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product GE Signa OpenSpeed 0.7T 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.
Code Information Product Numbers: 2138300-30, 2377062-5, 2377062-30 and unknown; Serial Numbers: 00000198709MR8, 00000204838MR7, 00000253102MR8, 00000003047YR8, 00000201708MR5, 00000000124YR8, 00000000137YR0, 00000199443MR3, 00000216407MR7, 00000000122YR2, 00000228773MR8, 00000231591MR9, 00000250186MR4, 00000247252MR0, 00000000120YR6, 00000003028YR8, 00000234832MR4, 00000253104MR4, 00000243405MR8, 00000253103MR6, 00000233644MR4, 00000216405MR1, 00000215365MR8, 00000063511WMO 000, 00000193652MR5, 00000253039MR2, 00000253039MR2, 00000229303MR3, 00000221251MR2, 00000244232MR5, 00000208208MR9, 00000229305MR8, 00000192104MR8, 00000003026YR2, 00000194218MR4, 00000000132YR1, 00000000144YR6, 00000225273MR2, 00000208211MR3, 00000000111YR5, 00000239480MR7, 00000201901MR6, 00000237928MR7, 00000231592MR7, 00000000134YR7, 00000241693MR1, 00000962592YM2, 00000241695MR6, 00000000146YR1, 00000003030YR4, 00000003027YR0, 00000000127YR1, 00000217198MR1, 00000244231MR7, 00000208210MR5, 00000000118YR0, 00000216409MR3, 00000204837MR9, 00000226319MR2, 00000216409MR3, 00000239483MR1, 00000189862MR6, 00000233646MR9, 00000209713MR7, 00000201710MR1, 00000003023YR9, 00000225942MR2, 00000207493MR8, 00000231590MR1, 00000003042YR9, 00000230309MR7, 00000250185MR6, 00000000151YR1, 00000229306MR6, 00000237050MR0 000 (Scrapped), 00000202223MR4, 00000003043YR7, 00000239482MR3, 00000193653MR3, 00000206438MR4, 00000228024MR6, 00000217201MR3, 00000232328MR5, 00000208209MR7, 00000228023MR8, 00000000129YR7, 00000000106YR5, 00000003034YR6, 00000000152YR9, 00000221254MR6, 00000000142YR0, 00000003033YR8, 00000003029YR6, 00000003024YR7, 00000247256MR1, 00000239484MR9, 00000000149YR5, 00000209712MR9, 00000000113YR1, 00000239847MR7, 00000000150YR3, 00000000102YR4, 00000212511MR0, 00000003031YR2, 00000241126MR2, 00000241126MR2, 00000237930MR3, 00000225274MR0, 00000241692MR3, 00002397929MR5, 00000000131YR3, 00000000105YR7, 00000230308MR9, 00000229304MR1, 00000229302MR5, 00000228022MR0, 00000237051MR8, 00000196364MR4, 00000000155YR2, 00000194950MR2, 00000189633MR1, 00000241127MR0, 00000194219MR2, 00000000133YR9, 00000247255MR3, 00000000108YR1, 00000247253MR8, 00000226318MR4, 00000250184MR9, 00000207494MR6, 00000216406MR9, 00000231588MR5, 00000212515MR1, 00000197334MR6, 00000237926MR1, 00000003036YR1, 00000000109YR9, 00000230312MR1, 00000003044YR5, 00000237927MR9, 00000003035YR3, 00000951021YM5, 00000221253MR8, 00000000136YR2, 00000000119YR8 000, 00000003025YR4, 00000003022YR1, 00000222950MR8, 00000234834MR0, 00000212513MR6, 3050YR2, 00000204839MR5, 00000241694MR9, 00000237052MR6, 00000212514MR4, 00000250187MR2, 00000201709MR3, 00000239846MR9, 00000000128YR9, 00000234833MR2, 00000237053MR4, 00000003011YR4, 00000221250MR4, 00000173287MR4, 00000203386MR8, 00000203387MR6, 00000206439MR2, 00000281322MR8, 00000239845MR1 and 00000000100YR8.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has identified a potential safety issue with the Signa OpenSpeed and Signa Ovation MR Scanner tables that may impact patient safety. The table may begin lowering on its own while a patient is on the table. If this occurs while the table is in the magnet bore, the table may tilt and could result in patient injury. The patient's head or feet depending on patient orientation, may hit
FDA Determined
Cause 2
DESIGN: Device Design
Action GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 16, 2009 addressed to Hospital Administrators, Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. A GE Healthcare Field Engineer will schedule a field visit to correct the device. Further questions or concerns may be addressed to GE Healthcare at 1-262-521-6681.
Quantity in Commerce 171
Distribution Worldwide Distribution -- US including PR and states of AL, AZ, AR, CA, CO,CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MN, MS, MO,MT, NV, NH, NE, NJ, NY, NC, OH, OK,OR, PA, SC, SD, TN, TX, VA, WA, WV, WI and countries of BRAZIL CHINA, DENMARK, EGYPT, ENGLAND, GERMANY, GUATEMALA, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, OMAN, MEXICO, OMAN, PHILIPPINES, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES and VENEZUELA.
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
510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC
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