FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1663-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-04-24
- Posted
- 2014-05-27
- Terminated
- 2015-01-08
- 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.
- Lot, serial or model codes
- model # 10432914 with serial numbers: 52126 52135 52108 52025 52101
- 510(k) numbers
- ["K111242"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28