GE Medical Systems, LLC: 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.

Recall number

Z-1557-2009

Recalling firm

GE Medical Systems, LLC

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.

Status

Terminated

Initiated

2009-04-16

Posted

2009-06-30

Terminated

2013-04-23

Reason

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

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K032795"]

PMA numbers

not on file

Product code

LNH

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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