Recall Z-1770-2017 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
| Date | Oct 17, 2016 |
| Status | Terminated |
| Reason | Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery. |
| Root cause | Software design (manufacturing process) |
| Action | Siemens mailed an Customer Safety Advisory Notice on October 17, 2016, to all affected customers to inform them of the corrective action they plan to take to correct the issue. The notice also informed users of the possible risks to patients and how the corrective action will be implemented. For further questions, please call (610) 448-6461. |
| Quantity | 3 systems distributed in the U.S. |
| Distribution | US Distribution to: DC and MD. |
| 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 |