Recall Z-2731-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
| Date | Aug 31, 2016 |
| Status | Terminated |
| Reason | GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue. |
| Root cause | Software design |
| Action | Consignees were sent on 8/31/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 67921 dated August 31, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 383 (US = 24;OUS = 359) |
| Distribution | US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI. OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, M |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143251 | SIGNA Creator, SIGNA Explorer Ge Healthcare (Ge Medical Systems, LLC), Feb 4, 2015 |