Terminated

GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the internal structure or organs of the entire body,

FDA Recall Z-2225-2008 · Posted 2008-09-11

Recalling FirmGE Healthcare

Recall StatusTerminated

Product CodeLNH

Date Initiated2008-03-28

Date Terminated2011-12-17

Product Quantity720 units (360 US / 360 OUS) estimate

Reason for Recall

Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis.

Firm Action

Customer Letter and Operator Manual addendum were sent directly to customers in August 2008. When the software correction is issued, GE Field Engineer will visit each site to implement the correction. (Not conducted yet)

Root Cause

Software change control

Distribution Pattern

AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA,WI, and WV. Countries of Argentina Australia Austria Belgium Brazil Canada Chile China Czech Republic Denmark Finland France French Polynesia Germany Greece Hong Kong India Indonesia Ireland Israel Italy Japan Korea Kuwait Lebanon Malaysia Mexico Netherlands New Zealand Norway Peru Philippines Russia Saudi Arabia Singapore South Africa Spain Sweden Switzerland Taiwan Taiwan Thailand Turkey United Arab Emirates and United Kingdom.

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.