Reported Oct 11, 2023 · Ongoing
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica
- MAGNETOM Spectra Siemens Model Number11060845 Used
- with the following MAGNETOM MRI Systems
MAGENTOM Amira 10836777 & 10838610MAGENTOM Free.Max 11408424 & 11408425MAGNETOM Free.Star 11408426 & 11408427MAGNETOM Mica 11292557MAGNETOM Sempra 10840815 & 10840816MAGNETOM Spectra 10655588 & 10837643(2)
- Over Ear Headphones SMN11060845 used
- with the following MAGNETOM MRI systemsMAGENTOM 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
- Lot codes and dates
23 of 23 products
Products covered by this recall Model / number Barcodes Product as published 1043291404056869006697MAGNETOM ALTEA 1134491504056869230719— 1141037104056869230726MAGNETOM AVANTO FIT 1151621604056869299266MAGNETOM AVANTOFit 1084957804056869006642— 1084957904056869006659MAGENTOM CIMA.X 11647158 04056869975221¿ 1168930404056869975245MAGNETOM LUMINA 1134491604056869230740— 1151615304056869260136MAGENTOM PRISMA 1084958204056869006727MAGENTOM PRISMAFit 1084958304056869006734MAGNETOM SKYRA 1043291504056869006703MAGENTOM SKYRA 1084958004056869006710MAGENTOM SKYRA FIT 1151621704056869299273MAGNETOM SOLA 1129145504056869164809— 1141023104056869217864MAGNETOM SOLA FIT 1141048204056869245195MAGNETOM TERRA 1088276404056869039190MAGNETOM TERRA.X 1137147704056869039190MAGNETOM Viato.Mobile 1168965204056869985558MAGNETOM VIDA - Amount recalled
- 3,470 units US; 13,265 worldwide
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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