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Terminated

GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. Indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.

FDA Recall Z-2210-2008 · Posted 2008-09-16

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeLNH
Date Initiated2007-10-01
Date Terminated2011-12-17
Product Quantity58

Reason for Recall

A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner.

Firm Action

A "GE Product Safety Notification" Customer letter addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists dated September 14, 2007 was was sent to consignees. The letter described the safety issue, affected product, safety instructions, product correction and contact information. The letter instructed customers to scan only from the Superior to Inferior direction, when using BrainwaveRT with 2D T1 weighted scan. A GE Field Engineer site visit was also conducted to implement the correction (FMI No, 60745 & 60746), which enables users to scan in both Inferior to Superior and Superior to Inferior directions and have no mismap between the functional and anatomical images.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution --- USA including states of AL, AZ, CA, CO , CT, FL, GA ,IA , IL, IN , KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, NE , NJ, NY , OH, OR, PA, PR,SD, TN, TX, UT, VA, WA, WI , and WV, the countries of Canada, Mexico, Brazil, New Zealand, Japan, Hong Kong, India, Korea, Australia, China, Italy, Lebanon, Netherlands, Norway, Russian Federation, South Africa, Turkey, Iran, Kuwait, Taiwan, Switzerland, Germany, France, Great Britain, Ireland, Denmark, Spain, Saudi Arabia, and Macau.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052293GE 1.5T AND 3.0T SIGNA HDX MR SYSTEMGe Medical Systems, LLC · 2005-09-21

Official Source

View FDA Recall →

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

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