Events

Recall of GE Signa OpenSpeed 0.7T MR System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52015
  • Event Risk Class
    Class 2
  • Event Number
    Z-1557-2009
  • Event Initiated Date
    2009-04-16
  • Event Date Posted
    2009-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81911
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • 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.
  • 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.

Device

GE Signa OpenSpeed 0.7T MR System
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA