Class 2 Device Recall MAGNETOM Amira, MAGNETOM Free.Star, MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica, MAGNETOM Spec

• Date Initiated by Firm: September 01, 2023
• Date Posted: September 29, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2648-2023
• Recall Event ID: 93047
• 510(K)Number: K223343 K220575 K183221 K153447 K220575 K210611
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• 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
• Code Information: (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
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer 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
• FDA Determined Cause: Process control
• Action: Siemens Medical Solutions USA, Inc., issued Urgent Medical Device Correction Letter to affected US customers via MR078/23/S and MR072/23/S beginning on September 1, 2023. Customers with valid email addresses will be emailed a copy of the CSAN via Adobe GigaSign. Letter states reason for recall, health risk and action to take: Siemens Healthineers will correct the issue by exchanging the headband of the affected over-ear headphones at customer sites with the field update MR073/23/S. This replacement program will start in October 2023. With the exchange of the headband the root cause is eliminated. In parallel the manufacturing error has been corrected for any new over-ear headphones with serial numbers greater than 32200. These new headphones are not affected by the issue. If you have additional questions, please contact your local service organization, or call 1-800-888-7436. Acknowledge Receipt of this Customer Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If you have received this notification by email via Adobe GigaSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this customer notification by the US Postal Service or FedEx delivery, please send an email to recallsandrefusals.team@siemens-healthineers.com acknowledging that you have read and understand the content provided.
• Quantity in Commerce: 3,470 units US; 13,265 worldwide
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LNH and Original Applicant = Siemens Medical Solutions USA Inc.; 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.