# FDA recall Z-2648-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2023-09-01.

## Product

(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845   Used with the following  MAGNETOM MRI Systems: MAGENTOM Amira   10836777 & 10838610; MAGENTOM Free.Max   11408424 & 11408425; MAGNETOM Free.Star   11408426 & 11408427; MAGNETOM Mica   11292557; MAGNETOM Sempra   10840815 & 10840816; MAGNETOM Spectra   10655588 & 10837643;  (2)  Over Ear Headphones   SMN: 11060845  used with the following MAGNETOM MRI systems: MAGENTOM Aera   10432914 MAGENTOM Altea   13344915 & 11410371 MAGNETOM Avanto   10849579 MAGNETOM Avanto Fit   11516216 MAGNETOM AvantoFit  10849578 MAGNETOM Cima.X   11647156 MAGNETOM Lumina   11344916 & 11516153 MAGNETOM Prisma   10849582 MAGNETOM PrismaFit   10849583 MAGNETOM Skyra   10432915 & 10849580 MAGNETOM Skrya Fit   11516217 MAGNETOM Sola   11291455 & 11410231 MAGNETOM Sola Fit   11410482 MAGNETOM Terra   10882764 MAGNETOM Terra.X   11371477 MAGNETOM V

## Reason for 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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2648-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-01
- **Report date:** 2023-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2648-2023

## Citation

> AI Analytics. FDA recall Z-2648-2023. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-2648-2023. Source: US FDA. Licensed CC0.

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