Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR75

FDA device recall Z-0592-2010 · posted 2010-01-11 · Terminated

Recall details

Recalling firm: GE Medical Systems, LLC
Reason for recall: GE Healthcare has recently become aware that the use of Confirma, Inc.'s CADstream in conjunction with the GE Healthcare's PURE (Phased Array Uniformity Enhancement) software for dynamic MRI imaging (Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems ) may require a modification to the study preference settings to p
Action taken: GE Healthcare issues an "Important Product Information" letter dated October 23, 2009. The letter was addressed to Hospital Administrators, Managers of Radiology and Radiologists. The letter listed the Issue, Affected Product Details, Instructions, Product correction and Contact Information. For further information, contact GE Healthcare at 1-262-548-2731.
Root cause: Software design
Status: Terminated
Product code: LNH
Quantity affected: 5460
Distribution: Worldwide Distribution -- All States in the US including DC and Puerto Rico. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA,
Date initiated: 2009-10-06
Date posted: 2010-01-11
Date terminated: 2012-08-03
Location: Waukesha, WI

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
DISCOVERY MR450 (K083147)	Ge Medical Systems, LLC	2008-11-04
SIGNA 3.0T MR750 SYSTEM (K081028)	Ge Medical Systems, LLC	2008-04-25
GE 1.5T SIGNA HDE MR SYSTEM (K052978)	Ge Medical Systems, LLC	2005-11-09
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (K052293)	Ge Medical Systems, LLC	2005-09-21
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM (K041476)	Ge Medical Systems, LLC	2004-06-17