(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM… — Class II medical device recall Z-2648-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-10-11, distributed nationwide. In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause
| Recall number | Z-2648-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2023-09-01 |
| Classified | 2023-09-29 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04056869006642, 04056869006659, 04056869006697, 04056869006703, 04056869006710, 04056869006727, 04056869006734, 04056869006819, 04056869020488, 04056869039176, 04056869039190, 04056869044521, 04056869164809, 04056869217864, 04056869230719, 04056869230726, 04056869230740, 04056869245188, 04056869245195, 04056869260136, 04056869260143, 04056869281742, 04056869281759, 04056869281766, 04056869299266 and 4 more |
| Serial numbers | 32200, 32200SERIAL, 7981 |
| Model numbers | 11060845 |
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 Vida 11060815 & 11516152 MAGNETOM VidaFit 11410481
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2648-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.