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Terminated

Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

FDA Recall Z-0693-2019 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2018-11-15
Date Terminated2021-01-17
Product Quantity3,849

Reason for Recall

Possible incorrect software version loaded.

Firm 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 Creator & Signa Explorer. GE Healthcare will inspect all affected systems and ensure the proper software version is installed. This will be performed at no cost to you. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Software design

Distribution Pattern

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, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mauritania, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam and Zambia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTGe Medical Systems, LLC · 2012-09-20K053009GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEMGE Medical Systems · 2005-11-17K033504GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEMGeneral Electric Co. · 2003-11-25K013636SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGYGE Medical Systems · 2002-01-24K0122001.5T INFINITY TWINSPEED MR SYSTEMGE Medical Systems · 2001-08-03K992746SIGNA HFO/I MAGNETIC RESONANCE SYSTEMGe Medical Systems, Inc. · 1999-11-09

Official Source

View FDA Recall →

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

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