Events

Recall of Device Recall Signa OpenSpeed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, 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
    56380
  • Event Risk Class
    Class 2
  • Event Number
    Z-0425-2011
  • Event Initiated Date
    2010-08-23
  • Event Date Posted
    2010-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93338
  • 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
    Magnetic resonance diagnostic device - Product Code LNH
  • Reason
    If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.
  • Action
    Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose.

Device

Device Recall Signa OpenSpeed
  • Model / Serial
    00000241692MR3 00000239483MR1 00000208209MR7 00000217199MR9 00000000155YR2 00000215365MR8 00000216405MR1 00000243405MR8 00000234832MR4 00000206438MR4 00000234833MR2 00000003024YR7 00000000149YR5 00000003011YR4 00000000102YR4 00000197334MR6 00000241694MR9 00000003042YR9 00000250185MR6 00000000128YR9 00000000113YR1 00000247253MR8 00000239847MR7 00000226319MR2 00000212515MR1 00000000142YR0 00000000105YR7 00000237052MR6 00000215364MR1 00000231592MR7 00000003026YR2 00000000108YR1 00000201710MR1 00000225942MR2 00000000110YR7 00000000135YR4 00000000153YR7 00000003036YR1 00000000109YR9 00000247256MR1 00000943610YM6 00000000131YR3 00000000101YR6 00000207493MR8 00000000127YR1 00000234834MR0 00000239484MR9 00000003030YR4 00000192104MR8 00000233646MR9 00000194218MR4 00000193652MR5 00000239482MR3 00000247254MR6 00000244231MR7 00000003022YR1 00000230312MR1 00000217202MR1 00000217198MR1 00000222950MR8 00000237053MR4 00000000111YR5 00000221250MR4 00000000144YR6 00000003051YR0 00000000133YR9 00000000151YR1 00000231590MR1 00000237927MR9 00000231588MR5 00000194219MR2 00000212514MR4 00000209713MR7 00000229303MR3 00000228024MR6 00000239846MR9 00000196364MR4 00000003025YR4 00000204837MR9 00000000119YR8 00002397929MR5 00000201709MR3 00000203386MR8 00000239480MR7 00000000118YR0 00000208210MR5 00000216409MR3 00000003039YR5 00000237930MR3 00000212513MR6 00000003034YR6 00000226318MR4 00000003023YR9 00000209712MR9 00000003050YR2 00000225273MR2 00000229306MR6 00000000129YR7 00000228022MR0 00000000136YR2 00000221253MR8 00000250187MR2 00000237928MR7 00000951021YM5 00000237926MR1 00000250184MR9 00000003027YR0 00000000146YR1 00000253104MR4 00000000132YR1 00000241127MR0 00000232328MR5 00000003035YR3 00000003044YR5 00000221254MR6 00000241695MR6 00000201901MR6 00000230308MR9 00000202223MR4 00000241693MR1 00000221251MR2 00000239845MR1 00000253103MR6 00000000150YR3 00000229304MR1 00000229305MR8 00000962592YM2 00000225274MR0 00000217201MR3 00000212511MR0 00000000120YR6 00000003041YR1 00000229302MR5 00000253039MR2 00000003033YR8 00000233644MR4 00000003029YR6 00000247255MR3 00000207494MR6 00000000106YR5 00000216406MR9 00000000103YR2 00000230309MR7 00000194950MR2 00000003031YR2 00000241126MR2 00000237051MR8 00000000134YR7 00000003043YR7 00000204839MR5 00000000100YR8 00000000152YR9 00000228023MR8 00000244232MR5 00000225941MR4 00000208211MR3 00000189633MR1 00000232329MR3 00000250186MR4 00000247252MR0 00000231591MR9 00000000122YR2 00000228773MR8 00000216407MR7 00000003047YR8 00000003049YR4 00000253102MR8 00000204838MR7 00000199443MR3 00000000137YR0 00000201708MR5 00000000124YR8 00000198709MR8 00000003028YR8 00000208208MR9 00000231589MR3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WV, and WI and countries of VENEZUELA, ECUADOR, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, SPAIN, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PHILIPPINE,S OMAN, MEXICO, KUWAIT, JAPAN, ITALY, HUNGARY, GERMANY, EGYPT, DENMARK, CHILE, CHINA, and BRASIL.
  • Product Description
    Signa OpenSpeed, 0.7T MR Systems (HFO3-5).
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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