Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens Medical Solutions USA, Inc: MRI Over-Ear Headphones Recalled for Image Artifact Risks

Agency Publication Date: September 29, 2023
Share:
Sign in to monitor this recall

Summary

Siemens Medical Solutions USA, Inc. is recalling approximately 3,470 units in the US (13,265 worldwide) of over-ear headphones (model 11060845) used with various MAGNETOM MRI systems. Lubricating grease within the headband may cause visible dot- or line-shaped artifacts to appear during head examinations. These artifacts can interfere with the clarity of the medical imaging, which is critical for accurate diagnosis. Consumers should contact Siemens Medical Solutions for guidance on how to manage or replace the affected equipment.

Risk

The presence of grease in the headband can create false markings (artifacts) on MRI scans that look like biological structures. This could lead to a misinterpretation of the medical images, potentially resulting in an incorrect diagnosis or unnecessary follow-up procedures for patients undergoing head examinations.

What You Should Do

  1. Identify if your facility uses Siemens Over-Ear Headphones model number 11060845.
  2. Check the serial numbers of your headphones to see if they fall within the affected range of 7981 to 32200.
  3. Verify the headphones against your specific MAGNETOM MRI system, including models such as Amira, Free.Max, Free.Star, Mica, Sempra, Spectra, Aera, Altea, Avanto, Cima.X, Lumina, Prisma, Skyra, Sola, Terra, Viato.Mobile, or Vida.
  4. Review the UDI (Unique Device Identifier) on your equipment, such as 04056869281742 (Free.Max), 04056869006819 (Amira), or 04056869044521 (Sempra), among others listed in the product details.
  5. Contact your Siemens Medical Solutions representative or the manufacturer directly at 1-888-826-9702 or through their website at www.siemens-healthineers.com for further instructions regarding repair or replacement.
  6. Contact the FDA's medical device recall hotline at 1-888-463-6332 for additional questions regarding this safety notification.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer mitigation of image artifacts

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Siemens Over-Ear Headphones for MAGNETOM MRI Systems
Model / REF:
11060845
10836777
10838610
11408424
11408425
11408426
11408427
11292557
10840815
10840816
10655588
10837643
10432914
11344915
11410371
11516216
10849578
10849579
11647158
11689304
11344916
11516153
10849582
10849583
10432915
10849580
11516217
11291455
11410231
11410482
10882764
11371477
11689652
11060815
11516152
11410481
UPC Codes:
04056869281742
04056869006819
04056869020488
04056869281759
04056869281766
04056869044521
04056869006697
04056869230719
04056869230726
04056869299266
04056869006642
04056869006659
04056869975221
04056869975245
04056869230740
04056869260136
04056869006727
04056869006734
04056869006703
04056869006710
04056869299273
04056869164809
04056869217864
04056869245195
04056869039190
04056869985558
04056869039176
04056869260143
04056869245188
Lot Numbers:
Serial Numbers 7981 to 32200

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93047
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: Siemens Medical Solutions USA, Inc; Direct medical device distribution
Manufactured In: United States
Units Affected: 3,470 units US; 13,265 worldwide
Distributed To: Nationwide
Agency Last Updated: October 23, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.