Recall Z-0693-2019 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
| Date | Nov 15, 2018 |
| Status | Terminated |
| Reason | Possible incorrect software version loaded. |
| Root cause | Software design |
| Action | On November 20, 2018 GE sent letters to all their consignees stating the following: If you have identified that your system has invalid software version, please contact GE Healthcare service representative immediately. This correction applies to some units of the following GE Healthcare MRI system types: Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity & Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO, Signa Ovation with Excite & 0.7T Signa OpenSpeed, Signa Ovation HD, Signa HDe, 1.5T Signa HDxt, Brivo MR355 & Optima MR360, Signa C |
| Quantity | 3,849 |
| Distribution | Worldwide Distribution - US Nationwide AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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 WY Albania, Algeria, Argentina, Armenia, Australia, Austria |
| 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 |
| K033504 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM General Electric Co., Nov 25, 2003 |
| K053009 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE Medical Systems, Nov 17, 2005 |
| K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT Ge Medical Systems, LLC, Sep 20, 2012 |
| K992746 | SIGNA HFO/I MAGNETIC RESONANCE SYSTEM Ge Medical Systems, Inc., Nov 9, 1999 |