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Terminated

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.

FDA Recall Z-2339-2015 · Posted 2015-08-05

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeLNH
Date Initiated2015-07-10
Date Terminated2015-11-19
Product Quantity82 (39 USA; 43 OUS)

Reason for Recall

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.

Firm Action

GE Healthcare sent an Urgent Medical Device Correction letter dated July 10, 2015, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees with questions were instructed to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMGe Medical Systems, LLC · 2004-06-17K040444GE SIGNA 3.0T WITH EXCITE MR SYSTEMGeneral Electric Co. · 2004-04-14K030874GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEMGeneral Electric Co. · 2003-03-28K013636SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGYGE Medical Systems · 2002-01-24K0122001.5T INFINITY TWINSPEED MR SYSTEMGE Medical Systems · 2001-08-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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