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MAGNETOM Skyra Fit

Model 11516217 · Siemens Healthcare GmbH · DI 04056869299273

LNH — System, Nuclear Magnetic Resonance Imaging · Class II · 21 CFR 892.1000

LNI — System, Nuclear Magnetic Resonance Spectroscopic · Class II · 21 CFR 892.1000

MOS — Coil, Magnetic Resonance, Specialty · Class II · 21 CFR 892.1000

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (3)

InitiatedRecall #ClassStatusReasonLink basis
2025-08-28Z-2661-2025Class IOpen, ClassifiedThere is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.k number procode
2025-08-28Z-2662-2025Class IOpen, ClassifiedThere is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.code info di
2023-09-01Z-2648-2023Class IIOpen, ClassifiedIn 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 usedcode info di

Adverse-event reports — MAUDE (3)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Injury: 2 · Malfunction: 1

24682019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.29/device2019-04: 0 reports for this device; peer average 3.05/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 2.13/device2019-10: 0 reports for this device; peer average 1.42/device2019-11: 1 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1.25/device2020-07: 0 reports for this device; peer average 1.69/device2020-08: 0 reports for this device; peer average 4/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1.36/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1.29/device2021-10: 0 reports for this device; peer average 1.38/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1.43/device2022-03: 0 reports for this device; peer average 1.14/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1.29/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1.33/device2022-10: 0 reports for this device; peer average 1.2/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1.31/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1.25/device2023-03: 0 reports for this device; peer average 2.81/device2023-04: 0 reports for this device; peer average 1.57/device2023-05: 0 reports for this device; peer average 1.77/device2023-06: 0 reports for this device; peer average 1.43/device2023-07: 1 reports for this device; peer average 1.39/device2023-08: 0 reports for this device; peer average 2.33/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.79/device2023-11: 0 reports for this device; peer average 2.22/device2023-12: 0 reports for this device; peer average 1.17/device2024-01: 0 reports for this device; peer average 1.17/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.25/device2024-04: 0 reports for this device; peer average 1.25/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1.4/device2024-08: 0 reports for this device; peer average 1.69/device2024-09: 0 reports for this device; peer average 1.25/device2024-10: 0 reports for this device; peer average 1.33/device2024-11: 0 reports for this device; peer average 1.89/device2024-12: 0 reports for this device; peer average 1.22/device2025-01: 0 reports for this device; peer average 4.67/device2025-02: 0 reports for this device; peer average 3.29/device2025-03: 0 reports for this device; peer average 2.41/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2.36/device2025-06: 0 reports for this device; peer average 4.95/device2025-07: 0 reports for this device; peer average 5.46/device2025-08: 0 reports for this device; peer average 7.53/device2025-09: 0 reports for this device; peer average 4.34/device2025-10: 0 reports for this device; peer average 5.1/device2025-11: 0 reports for this device; peer average 3.92/device2025-12: 0 reports for this device; peer average 7/device2026-01: 0 reports for this device; peer average 6.47/device2026-02: 1 reports for this device; peer average 3.8/device2026-03: 0 reports for this device; peer average 3.44/device2026-04: 0 reports for this device; peer average 3.62/device2026-05: 0 reports for this device; peer average 6.38/device2026-06: 0 reports for this device; peer average 3/device020304050607101112020307080910120102030405070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0302.29
2019-0403.05
2019-0501
2019-0601
2019-0702.13
2019-1001.42
2019-1111
2019-1201
2020-0201
2020-0301.25
2020-0701.69
2020-0804
2020-0901
2020-1001
2020-1201.36
2021-0101
2021-0201
2021-0301
2021-0403
2021-0501
2021-0701
2021-0801
2021-0901.29
2021-1001.38
2021-1101
2021-1201
2022-0101
2022-0201.43
2022-0301.14
2022-0401
2022-0501
2022-0601.29
2022-0701
2022-0801
2022-0901.33
2022-1001.2
2022-1101
2022-1201.31
2023-0101
2023-0201.25
2023-0302.81
2023-0401.57
2023-0501.77
2023-0601.43
2023-0711.39
2023-0802.33
2023-0902
2023-1001.79
2023-1102.22
2023-1201.17
2024-0101.17
2024-0201
2024-0301.25
2024-0401.25
2024-0501
2024-0601
2024-0701.4
2024-0801.69
2024-0901.25
2024-1001.33
2024-1101.89
2024-1201.22
2025-0104.67
2025-0203.29
2025-0302.41
2025-0402
2025-0502.36
2025-0604.95
2025-0705.46
2025-0807.53
2025-0904.34
2025-1005.1
2025-1103.92
2025-1207
2026-0106.47
2026-0213.8
2026-0303.44
2026-0403.62
2026-0506.38
2026-0603
This device (reports/month)Average device in LNH, LNI, MOS (reports/device/month)

Regulatory clearances

  • K250443 SESE 2025-06-16 (k number procode)
  • K220589 SESE 2022-05-13 (k number procode)

Predicate lineage

K220589 — cites (transitively): K173592 (d1), K181613 (d1), K203443 (d1), K153343 (d2), K162102 (d2), K163312 (d2), K121434 (d2), K192496 (d2), K192924 (d2), K202014 (d2), K082427 (d3), K091114 (d3), K103274 (d3), K133435 (d3), K141977 (d3), K151579 (d3), K151597 (d3), K101347 (d3), K123510 (d3), K181322 (d3), K182129 (d3), K182299 (d3), K183244 (d3), K183254 (d3), K192462 (d3), K041112 (d4), K072237 (d4), K053042 (d4), K073194 (d4), K090038 (d4), K121160 (d4), K121459 (d4), K132831 (d4), K132951 (d4), K140253 (d4), K140998 (d4), K130885 (d4), K132119 (d4), K050263 (d4), K143311 (d4), K150843 (d4), K170396 (d4), K173617 (d4), K173600 (d4), K181433 (d4), K163234 (d4), K180336 (d4), K092519 (d5), K123938 (d5), K133226 (d5), K152283 (d5), K120315 (d5), K130749 (d5), K133401 (d5), K151353 (d5), K163294 (d5), K110315 (d6), K123375 (d6), K103429 (d6), K123737 (d6), K130262 (d6), K081453 (d7), K070403 (d7), K090932 (d7), K892410 (d7), K113448 (d7), K060873 (d7), K071925 (d7), K083166 (d7), K100141 (d7) — cited as predicate by K250443, K252239

K250443 — cites (transitively): K153343 (d1), K191040 (d1), K203443 (d1), K213693 (d1), K220151 (d1), K220589 (d1), K221733 (d1), K231560 (d1), K231587 (d1), K232494 (d1), K232535 (d1), K240608 (d1), K250433 (d1), K133435 (d2), K141977 (d2), K151579 (d2), K151597 (d2), K123584 (d2), K143196 (d2), K150843 (d2), K192496 (d2), K192924 (d2), K202014 (d2), K181613 (d2), K190757 (d2), K173592 (d2), K213805 (d2), K220939 (d2), K220575 (d2), K162102 (d2), K173446 (d2), K183111 (d2), K232482 (d2), K072728 (d3), K112020 (d3), K120579 (d3), K073194 (d3), K090038 (d3), K121160 (d3), K121434 (d3), K121459 (d3), K123510 (d3), K132831 (d3), K132951 (d3), K140253 (d3), K140998 (d3), K063877 (d3), K093621 (d3), K130885 (d3), K132119 (d3), K050263 (d3), K143311 (d3), K142755 (d3), K163312 (d3), K101347 (d3), K181322 (d3), K182129 (d3), K182299 (d3), K183244 (d3), K183254 (d3), K192462 (d3), K210611 (d3), K181433 (d3), K073003 (d4), K091373 (d4), K092519 (d4), K041112 (d4), K072237 (d4), K082427 (d4), K043469 (d4), K061214 (d4), K083524 (d4), K091114 (d4), K103274 (d4), K123938 (d4), K140606 (d4), K170396 (d4), K173617 (d4), K173600 (d4), K163234 (d4), K180336 (d4), K082331 (d4), K183221 (d4), K053042 (d5), K022395 (d5), K133226 (d5), K152283 (d5), K120315 (d5), K130749 (d5), K133401 (d5), K151353 (d5), K163294 (d5), K163211 (d5), K110315 (d6), K123375 (d6), K103429 (d6), K123737 (d6), K130262 (d6), K081453 (d7), K070403 (d7), K090932 (d7), K892410 (d7), K113448 (d7), K060873 (d7), K071925 (d7), K083166 (d7), K100141 (d7) — cited as predicate by K252838, K253023

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Siemens Healthcare GmbH

  • NAI 2014-09-25 Siemens AG/Siemens Healthcare GmbH · 0 citations
  • VAI 2011-06-09 Siemens Healthcare GmbH · 1 citations
  • NAI 2010-09-14 Siemens AG/Siemens Healthcare GmbH · 0 citations