—#81911

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.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K032795
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-04-16
Posted by FDA: 2009-06-30
Terminated: 2013-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81911. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.