Home / Recalls / Medical Devices
GE Healthcare recalls GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinit
Recalled August 12, 2015 · FDA recall Z-2339-2015 · GE Healthcare
Hazard
A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation. · FDA Class II
Units
82 (39 USA; 43 OUS)
Sold at
Worldwide Distribution - US (nationwide) and Internationally to UNITED ARAB EMIRATES, ARGENTINA, BRAZIL, INDIA, EGYPT, CHINA, FINLAND, FRANCE, UNITED KINGDOM, HUNGARY, JAPAN, INDONESIA, KOREA, MEXICO, NEW ZEALAND, CANADA, AUSTRALIA, ITALY, RUSSIAN FEDERATION, TAIWAN, and SOUTH AFRICA.
Description
A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.
Product
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi. Whole body magnetic resonance diagnostic imaging scanners.
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →