Magnetom Avanto MRI System, Model 7391167 recallZ-1395-04 · Siemens Medical Solutions USA, Inc · initiated Jul 28, 2004
Terminated All recalls posted in August 2004
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
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
FDA root cause category: Other
What the company is doing
The recalling firm issued a Customer Safety Advisory letter via certified mail to their customers per Update Instructions MR028/04/S. The letter informs customers of the potential issue and provides instructions to avoid its occurence.
Recall details
- Recall number
- Z-1395-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 28, 2004
- Posted by the FDA
- Aug 24, 2004
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 29 units
- Product code
- LNH
- FDA submissions
- K032428
- Distribution
- The products were shipped to 39 medical facilities in CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, and VA.
Product description
Magnetom Avanto MRI System, Model 7391167
Code information (models, lots, serial numbers)
Serial numbers 25001 - 25129
Other devices under the same FDA submission
1 device cleared under K032428 — 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 Avanto 10684332Siemens Healthcare GmbH · System, nuclear magnetic resonance imaging3 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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