Lower risk Medical device recall · FDA · Published September 1, 2023

Siemens Over-Ear Headphones May Cause MRI Artifacts in Head Exams

Siemens recalls over-ear headphones used with specific MRI systems due to lubricating grease causing visible artifacts during head scans. Affected models include MAGNETOM Amira, Free.Max, Free.Star, Sempra, Mica, Spectra and others.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2648-2023Medical device Siemens ›

Lower-risk recall

In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418

✎ GovInfoNow plain-language explainer

Siemens is recalling over-ear headphones used with certain MRI machines because lubricating grease inside the headband can create visible artifacts during head scans. This issue affects specific models and serial numbers, but does not pose a safety risk to users. Read more at govinfonow.com/recall/57399-siemens-over-ear-headphones-may-cause-mri-artifacts-in-head.

Source Summary by GovInfoNow · govinfonow.com/recall/57399-siemens-over-ear-headphones-may-cause-mri-artifacts-in-head · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2648-2023

Cite this page

“Siemens Over-Ear Headphones May Cause MRI Artifacts in Head Exams.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57399-siemens-over-ear-headphones-may-cause-mri-artifacts-in-head. Based on FDA recall #Z-2648-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2648-2023%22&limit=1).

The FDA announced on Sept. 1, 2023, that Siemens Medical Solutions USA, Inc. recalled over-ear headphones due to potential imaging artifacts during head examinations. The agency issued recall number Z-2648-2023 for the Class II device.

How to tell if you have it

Siemens Over-ear headphones, Model Number 11060845, Serial Numbers 7981 to 32200
Used with MAGNETOM Amira (UDI: 04056869006819, 04056869020488)
Used with MAGNETOM Free.Star (UDI: 04056869281766, 0405686981773)
Used with MAGNETOM Sempra (UDI: 04056869044521)
Used with MAGNETOM Free.Max (UDI: 04056869281742, 04056869281759)
Used with MAGNETOM Mica
Used with MAGNETOM Spectra
Used with MAGNETOM Aera (UDI: 04056869006697)
Used with MAGNETOM Altea (UDI: 04056869230719, 04056869230726)
Used with MAGNETOM Avanto (UDI: 04056869006659)
Used with MAGNETOM Avanto Fit (UDI: 04056869299266)
Used with MAGNETOM AvantoFit (UDI: 04056869006642)
Used with MAGNETOM Cima.X (UDI: 04056869975221, 04056869975245)
Used with MAGNETOM Lumina (UDI: 04056869230740, 04056869260136)
Used with MAGNETOM Prisma (UDI: 04056869006727)
Used with MAGNETOM PrismaFit (UDI: 04056869006734)
Used with MAGNETOM Skyra (UDI: 04056869006703, 04056869006710)
Used with MAGNETOM Skrya Fit (UDI: 04056869299273)
Used with MAGNETOM Sola (UDI: 04056869164809, 04056869217864)
Used with MAGNETOM Sola Fit (UDI: 04056869245195)
Used with MAGNETOM Terra (UDI: 04056869039190)
Used with MAGNETOM Terra.X (UDI: 04056869039190)
Used with MAGNETOM Vida (UDI: 04056869039176, 04056869260143)
Used with MAGNETOM VidaFit (UDI: 04056869245188)

The hazard

According to the FDA, lubricating grease within the headband may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls include a June 8, 2026 recall for loose screws in the ARTIS icono Ceiling Monitor and a May 20, 2026 recall for movement loss risks in the ARTIS Icono Biplane. A March 12, 2026 recall addressed inaccurate 3D scans due to radiation exposure in the Siemens ARTIS Pheno VE30A/VE40A.

How to tell if you have this one

Check if your headphones have the model number 11060845 and are used with specific Siemens MRI systems listed in the recall notice. The serial numbers range from 7981 to 32200 for some models.

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify your headphones' model number and serial numbers to confirm if they are in the recall list.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 40 days after the firm started it.

Sep 1, 2023Firm started the recall
Sep 29, 2023FDA classified it Class II
Oct 11, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Which MRI systems are affected?

The headphones are used with specific Siemens MRI systems including MAGNETOM Amira, Free.Max, Free.Star, Sempra, Mica, Spectra, Aera, Altea, Avanto, Cima.X, Lumina, Prisma, Skyra, Sola, and Vida.

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Link to this recall

<a href="https://govinfonow.com/recall/57399-siemens-over-ear-headphones-may-cause-mri-artifacts-in-head">Siemens Over-Ear Headphones May Cause MRI Artifacts in Head Exams (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2648-2023 (September 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2648-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.