FDA Recall Open, Classified

(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

Recall: Z-2648-2023 · Initiated September 1, 2023

Recall

Recall Number: Z-2648-2023
Event Number: 93047
Firm: Siemens Medical Solutions USA, Inc
FEI Number: 2240869
Product Code: LNH
Status: Open, Classified
Root Cause: Process control
Initiated: September 1, 2023
Posted: September 29, 2023
Address: 40 Liberty Blvd, Malvern, PA, 19355-1418

Description

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

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 [email protected] acknowledging that you have read and understand the content provided.

Distribution

US Nationwide distribution.

Quantity

3,470 units US; 13,265 worldwide