MAGNETOM Aera magnetic resonance system recallZ-1663-2014 · Siemens Medical Solutions USA, Inc · initiated Apr 24, 2014
Class II Terminated All recalls posted in May 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
FDA root cause category: Labeling design
What the company is doing
A customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals.
Recall details
- Recall number
- Z-1663-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 24, 2014
- Posted by the FDA
- May 27, 2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 5
- Product code
- LNH
- FDA submissions
- K111242
- Distribution
- Distributed in the states of MN, CA, CO, TX, and IA.
Product description
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.
Code information (models, lots, serial numbers)
model # 10432914 with serial numbers: 52126 52135 52108 52025 52101
Other devices under the same FDA submission
2 devices cleared under K111242 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MAGNETOM Skyra 10432915Siemens Healthcare GmbH · System, nuclear magnetic resonance imaging2 recalls8 reports
- MAGNETOM Aera 10432914Siemens Healthcare GmbH · System, nuclear magnetic resonance imaging1 recall25 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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