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Terminated

Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.

FDA Recall Z-0462-2011 · Posted 2010-11-24

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2009-05-11
Date Terminated2015-11-24
Product Quantity1464

Reason for Recall

Signa MR Excite" 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip along the phase encode direction and incorrect annotation, which may result in incorrect localization of anatomy in oblique axial images with the pulse sequences.

Firm Action

GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 21, 2009. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Field Engineers will contact customers to schedule a field modification of the affected products to address this issue. Customers can contact GE Healthcare at 262 521-6100 about this issue.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution: Throughout USA except states of AK, VT and WY, and the countries of: Argentina, Australia, Bulgaria, Brazil, China, Canada, Switzerland, Chile, Colombia, Czech Republic, Ecuador, Egypt, Spain, Finland, France, Great Britain, Guatemala, Honduras, Croatia, Hungary, Indonesia, Ireland, India, Iran, Iceland, Italy, Japan, Kenya, South Korea, Kuwait, Lebanon, Luxembourg, Libya, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Puerto Rico, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Syria, Thailand, Tunisia, Turkey, Taiwan, Venezuela, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013636SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGYGE Medical Systems · 2002-01-24

Official Source

View FDA Recall →

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

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