Class 2 Device Recall GE Signa OpenSpeed 0.7T MR System

• Date Initiated by Firm: April 16, 2009
• Date Posted: June 30, 2009
• Recall Status: Terminated on April 23, 2013
• Recall Number: Z-1557-2009
• Recall Event ID: 52015
• 510(K)Number: K032795
• 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 WI 53188-1615
• For Additional Information Contact: 262-544-3894
• 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: 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 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, LLC