Events

Recall of Device Recall Signa Infinity Signa Infinity Twinspeed Signa Vibrant Signa HDx Signa HDxt Signa HDxi

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
    65133
  • Event Risk Class
    Class 2
  • Event Number
    Z-1943-2013
  • Event Initiated Date
    2011-11-21
  • Event Date Posted
    2013-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117974
  • 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
    Screen save images are included in wrong exam due to duplicate uid creation. this may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the signa hdxt 1.5t system, internal investigation revealed that the issue also impacts multiple ge healthcare mr systems.
  • Action
    GE Healthcare communicated internally to their Service Team the directions for completing the correction on the customers' systems. GE Healthcare's recall strategy was to update all affected systems that were distributed. At this time,Week of 02/06/2012, deployment of this recall is considered complete. Should you have any questions or require additional information, please contact Regulatory Affairs Leader by telephone at 262-548-2608 or email paulcorrigan@ge.com.

Device

Device Recall Signa Infinity Signa Infinity Twinspeed Signa Vibrant Signa HDx Signa HDxt Signa HDxi
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including DC and Puerto Rico and countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIDJAN, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIAN, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU. PHILIPPINES, POLAND, PORTUGAL, REPUBLIC OF MACEDONIA, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TUR,EKY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, YUGOSLAVIA, MALAWI, MAURITANIA, NIGERIA, UKRAINE, IVORY COST, OMAN, ZAMBIA, UZBEKISTAN, ESTONIA, IRAQ, and JAMAICA.
  • Product Description
    SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY || GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM || GE SIGNA 3.0T WITH EXCITE MR SYSTEM || GE SIGNA EXCITE 1.5T MR SYSTEM || GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx || Signa HDxt || Signa HDi || Signa Vibrant || GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) || GE 1.5T SIGNA HDe MR SYSTEM || GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM || GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM || GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM || The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
  • 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