Recall Z-1598-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
| Date | May 3, 2016 (initiated Apr 13, 2016) |
| Status | Terminated |
| Reason | The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet. |
| Root cause | Vendor change control |
| Action | Siemens mailed to customers on April 13, 2016, a Customer Safety Advisory Notice, MR013/16/S, to inform them of the actions to take to prevent a possible hazard to persons and equipment. Customers were informed that they will be contacted by one of Siemens' service organization who will schedule an appointment to perform a correction, which is to exchange the top cover. |
| Quantity | 8 systems |
| Distribution | US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101347 | MAGNETOM AERA; MAGNETOM SKYRA Siemens Medical Solutions USA, Inc., Oct 1, 2010 |