Recall Z-0258-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
| Date | Nov 10, 2015 (initiated Aug 31, 2015) |
| Status | Terminated |
| Reason | When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans. |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated August 31, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Radiology Department Managers, & 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 | 350 |
| Distribution | Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMAN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM Ge Medical Systems, LLC, Sep 21, 2005 |