Recall Z-1663-2014 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
| Date | May 27, 2014 (initiated Apr 24, 2014) |
| Status | Terminated |
| Reason | Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals. |
| Root cause | Labeling design |
| Action | A customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals. |
| Quantity | 5 |
| Distribution | Distributed in the states of MN, CA, CO, TX, and IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111242 | MAGNETOM AERA AND MAGNETOM SKYRA Siemens Medical Solutions USA, Inc., Nov 23, 2011 |