Recall Z-1396-04 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Magnetom Harmony MRI System Model number 7106714
| Date | Aug 24, 2004 (initiated Jul 28, 2004) |
| Status | Terminated |
| Reason | An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows |
| Root cause | Other |
| Action | The recalling firm issued a Customer Safety Advisory letter via certified mail to their customers per Update Instructions MR028/04/S. The letter informs customers of the potential issue and provides instructions to avoid its occurence. |
| Quantity | 1 unit |
| Distribution | The products were shipped to 39 medical facilities in CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970852 | MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE) Siemens Medical Solutions USA, Inc., Jun 5, 1997 |