Recall Z-0110-2019 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350), 1.5T SIGNA ECHOSPEED, 1.5T SIGNA EXCITE, 1.5T SIGNA EXCITE MRI, 1.5T SIGNA VIBRANT 16CH FIXED, 3.0T MRI TWINSPEED 8CH, 3.0
| Date | Jun 7, 2018 |
| Status | Terminated |
| Reason | The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch. |
| Root cause | Software change control |
| Action | The firm, GE Healthcare, notified its customers on or before 06/07/2018 via a letter entitled "URGENT MEDICAL DEVICE CORRECTION". The letter described the product, problem and actions to be taken. The letter informed customers that GE Healthcare will inspect all affected systems and ensure the proper software version is installed. Instructions for customers to confirm the current software included the following steps: 1. Click on tools icon located on the top left of the screen; 2. Click on Service Browser Button; 3. The MR Service Desktop browser will launch (may take 1 minute to launch); |
| Quantity | 5,200 total units |
| Distribution | Worldwide Distribution: US (nationwide) including states of:: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and countries of: Algeria, Argentina, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012200 | 1.5T INFINITY TWINSPEED MR SYSTEM GE Medical Systems, Aug 3, 2001 |
| K013636 | SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE Medical Systems, Jan 24, 2002 |
| K030874 | GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM General Electric Co., Mar 28, 2003 |
| K040444 | GE SIGNA 3.0T WITH EXCITE MR SYSTEM General Electric Co., Apr 14, 2004 |
| K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM Ge Medical Systems, LLC, Jun 17, 2004 |
| K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM Ge Medical Systems, LLC, Sep 21, 2005 |