medical Class II Updated 2023-10-11

Siemens Medical Solutions USA, Inc recalls (1) Over-ear headphones used with the MAGNETOM Amira MAGNETO

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: (1)Model/Material Number/UDI: MAGNETOM FREE.MAX 11408425 UDI: 04056869281742; MAGNETOM AMIRA 10836777 UDI: 04056869006819; MAGENTOM AMIRA 10838610 UDI: 04056869020488; MAGNETOM FREE.Max 11408424 UDI: 04056869281759; MAGNETOM Free.Star 11408426 UDI: 04056869281766; MAGNETOM Free.Star 11408427 UDI: 0405686981773; MAGNETOM Mica 11292557 NA; MAGNETOM Sempra 10840815 UDI: 04056869044521. Over Ear Headphones 11060845 (Serial Numbers 7981 to 32200Serial Numbers; 7981 to 32200 (2) Model UDI-DI MAGNETOM AERA 10432914 04056869006697 MAGNETOM ALTEA 11344915 04056869230719 11410371 04056869230726 MAGNETOM AVANTO FIT 11516216 04056869299266 MAGNETOM AVANTOFit 10849578 04056869006642 10849579 04056869006659 MAGENTOM CIMA.X 11647158 04056869975221¿ 11689304 04056869975245 MAGNETOM LUMINA 11344916 04056869230740 11516153 04056869260136 MAGENTOM PRISMA 10849582 04056869006727 MAGENTOM PRISMAFit 10849583 04056869006734 MAGNETOM SKYRA 10432915 04056869006703 MAGENTOM SKYRA 10849580 04056869006710 MAGENTOM SKYRA FIT 11516217 04056869299273 MAGNETOM SOLA 11291455 04056869164809 11410231 04056869217864 MAGNETOM SOLA FIT 11410482 04056869245195 MAGNETOM TERRA 10882764 04056869039190 MAGNETOM TERRA.X 11371477 04056869039190 MAGNETOM Viato.Mobile 11689652 04056869985558 MAGNETOM VIDA 11060815 04056869039176 11516152 04056869260143 MAGNETOM VIDAFit 11410481 04056869245188 Over Ear Headphones 11060845 (Serial Numbers 7981 to 32200
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