Device Recall Signa Infinity Signa Infinity Twinspeed Signa Vibrant Signa HDx Signa HDxt Signa HDxi 의 리콜

Radiology Devices

2

No

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.

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.