(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mic

FDA device recall Z-2648-2023 · posted 2023-09-29 · Open, Classified

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

LNH

Quantity affected

3,470 units US; 13,265 worldwide

Distribution

US Nationwide distribution.

Date initiated

2023-09-01

Date posted

2023-09-29

Location

Malvern, PA

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