GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300…

Date posted by the FDA

Sept. 11, 2008

Status

Terminated

Filed by

GE Healthcare

Product

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,

Reason

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.

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.

Quantity

720 units (360 US / 360 OUS) estimate

Codes and lots

000000000R1597 000000000R5210 000000000R5871 00000007557YR2 00000007496YR3 00000010285YR5 00000008560YR5 00000009025YR8 0000000B523YR3 00000006697YR7 00000007562YR2 00000005539YR2 00000006662YR1 00000007568YR9 00000007108YR4 00000007497YR1 00000007542YR4 00000008116YR6 00000008322YR0 00000008384YR0 00000009538YR0 00000010300YR2 00000007114YR2 00000006604YR3 00000008325YR3 00000009872YR3 00000006557YR3 00000009534YR9 00000007563YR0 00000009854YR1 00000006722YR3 00000007541YR6 00000008376YR6 00000008317YR0 00000008099YR4 00000009006YR8 00000007126YR6 00000008351YR9 00000010283YR0 00000009009YR2 00000005981YR6 00000008100YR0 00000006710YR8 00000008098YR6 00000007890YR7 00000006594YR6 00000008539YR9 00000007871YR7 00000007564YR8 00000005992YR3 00000007556YR4 00000007498YR9 00000007878YR2 00000007565YR5 00000007877YR4 00000007100YR1 00000008993YR* 00000007097YR9 00000009436YR7 00000009419YR3 00000006698YR5 00000007530YR9 00000009858YR2 00000009082YR9 00000007551YR5 00000007870YR9 00000007508YR5 00000009539YR8 00000008404YR6 00000006713YR2 00000008339YR4 00000008396YR4 00000009773YR3 00000009576YR0 00000008352YR7 00000006707YR4 00000006678YR7 00000007582YR0 00000007882YR4 00000007887YR3 00000010511YR4 00000006558YR1 00000009566YR1 00000008197YR6 00000007087YR0 00000007859YR2 00000009060YR5 00000008387YR3 00000009461YR5 00000008342YR8 00000005564YRO 00000007133YR2 00000005537YR6 00000006737YR1 00000006757YR9 00000010160YR0 00000010396YR0 00000005564YR0 00000005532YR7 00000009052YR2 00000007532YR5 00000006690YR2 00000008355YR0 00000006691YR0 00000007099YR5 00000006574YR8 00000009545YR5 00000005970YR9 00000007858YR4 00000007856YR8 00000006682YR9 00000008338YR6 00000005927YR5 00000007549YR9 00000007122YR5 00000006696YR9 00000006715YR7 00000009979YR6 00000009553YR9 00000010525YR4 00000005222YR5 00000010132YR9 00000010432YR3 00000010284YR8 00000010048YR7 00000009618YR0 00000009421YR9 00000009848YR3 00000009578YR6 00000006738YR9 00000009084YR5 00000007866YR7 00000007865YR9 00000007514YR3 00000010045YR3 00000009587YR7 00000009986YR1 00000009766YR7 00000006721YR5 00000009531YR5 00000010028YR9 00000006600YR1 00000010395YR2 00000006727YR2 00000010134YR5 00000007544YR0 00000010289YR7 00000005548YR3 00000007547YR3 00000007555YR6 00000007853YR5 00000006572YR2 00000006670YR4 00000006673YR8 00000008332YR9 00000009867YR3 00000005974YR1 00000006669YR6 00000009982YR0 00000009774YR1 00000010163YR4 00000005215TR9 00000009049YR8 00000007117YR5 00000008378YR2 00000008373YR3 00000007594YR5 00000006716YR5 00000009617YR2 00000008391YR5 00000008059YR8 00000005216YR7 00000006566YR4 00000008337YR8 00000008392YR3 00000009007YR6 00000005536YR8 00000009775YR8 00000007572YR1 00000009599YR2 00000007862YR6 00000007507YR7 00000006570YR6 00000006708YR2 00000006714YR0 00000009845YR9 00000007591YR1 00000007561YR4 00000008335YR2 00000009438YR3 00000007579YR6 00000009547YR1 00000008327YR9 00000009028YR2 00000008061YR4 00000006667YR0 00000006556YR5 00000010059YR4 00000006660YR5 00000006568YR0…

Recall started

March 28, 2008

Device type

System, Nuclear Magnetic Resonance Imaging

Root cause (FDA)

Software change control

What the company told customers

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)

Recall number

Z-2225-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2225-2008. The agency record governs; check it and the company before acting.