Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe

FDA device recall Z-0935-2013 · posted 2013-03-11 · Terminated

Recall details

Recalling firm: GE Healthcare, LLC
Reason for recall: An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
Action taken: GE Healthcare sent an Urgent Field Safety Notice dated May 5, 2011, to all affected customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Customers were instructed to open only one patient report at a time when editing a report in SR Viewer. US Customers did not receive a customer letter, however all US systems have been updated. For questions customers were instructed to contact their local Sales/Service Representative. For questions regarding this recall call 262-513-4122.
Root cause: Software design
Status: Terminated
Product code: LNH
Quantity affected: 4026 (1672 US; 2354 OUS)
Distribution: Worldwide Distribution - USA (All States in continental USA including PR except RI.). Internationall to: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BELARUS, BELGIUM, BULGARIA, BOSNIA
Date initiated: 2011-05-10
Date posted: 2013-03-11
Date terminated: 2016-06-30
Location: Waukesha, WI

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