Recall Z-2648-2023— Siemens Medical Solutions USA, Inc
Class II · Ongoing
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2023-09-01. It names 5 FDA 510(k) clearances: K223343, K220575, K210611 and 2 more. 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: 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.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-01
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K223343 — MAGNETOM Amira; MAGNETOM Sempra
- K220575 — MAGNETOM Free.Max, MAGNETOM Free.Star
- K210611 — MAGNETOM Free.Max
- K183221 — MAGNETOM Amira, MAGNETOM Sempra
- K153447 — MAGNETOM Spectra
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
(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
Data sourced from openFDA. This site is unofficial and independent of the FDA.