Reported Jun 4, 2014 · Terminated

MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355

Is this the product you have?

  • 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.
Lot codes and dates
  • model # 10432914
  • with serial numbers52126 52135 52108 52025 52101
Amount recalled
5

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Siemens Medical Solutions USA, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 8, 2015 · Data as of Sep 19, 4:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.