Recall Z-2648-2023 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
(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 & 108408
| Date | Sep 29, 2023 (initiated Sep 1, 2023) |
| Status | Open, Classified |
| 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 |
| Root 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 elimi |
| Quantity | 3,470 units US; 13,265 worldwide |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153447 | MAGNETOM Spectra Siemens Medical Solutions USA, Inc., Mar 31, 2016 |
| K183221 | MAGNETOM Amira, MAGNETOM Sempra Siemens Medical Solutions USA, Inc., Feb 14, 2019 |
| K210611 | MAGNETOM Free.Max Siemens Medical Solutions USA, Inc., Jul 1, 2021 |
| K220575 | MAGNETOM Free.Max, MAGNETOM Free.Star Siemens Medical Solutions USA, Inc., Jun 24, 2022 |
| K223343 | MAGNETOM Amira; MAGNETOM Sempra Siemens Medical Solutions USA, Inc., Mar 28, 2023 |