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Flex Large 4 MR coil 3T

Model 08625761 · Siemens Healthcare GmbH · DI 04056869014388

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

OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance · Class II · 21 CFR 892.1200

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2015-12-07Z-0467-2016Class IITerminatedPossible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others.k number procode

Adverse-event reports — MAUDE (0)

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.

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: 0 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: 0 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: 0 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 3.58/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
2019-1101
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
2023-0701.39
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
2026-0203.8
2026-0303.44
2026-0403.58
2026-0506.38
2026-0603
This device (reports/month)Average device in LNH, LNI, MOS, OUO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K121434 — cites (transitively): K082427 (d1), K091114 (d1), K103274 (d1), K053042 (d2) — cited as predicate by K123510, K123920, K123938, K130262, K130749, K132831, K132951, K133692, K140666, K141977, K143020, K152602, K163234, K170396, K170840, K181613, K191050, K220018

K133226 — cites (transitively): K103429 (d1), K123737 (d1), K123938 (d1), K081453 (d2), K082427 (d2), K113448 (d2), K121434 (d2), K091114 (d3), K103274 (d3), K053042 (d4) — cited as predicate by K142098, K163234

K151579 — cites (transitively): K130885 (d1), K132119 (d1), K132951 (d1), K141977 (d1), K082427 (d2), K101347 (d2), K123510 (d2), K123938 (d2), K121434 (d2), K073194 (d2), K090038 (d2), K121160 (d2), K121459 (d2), K132831 (d2), K133435 (d2), K140253 (d2), K140998 (d2), K041112 (d3), K072237 (d3), K091114 (d3), K103274 (d3), K092519 (d3), K053042 (d4) — cited as predicate by K153343, K161795

K153343 — cites (transitively): K133435 (d1), K141977 (d1), K151579 (d1), K151597 (d1), K073194 (d2), K090038 (d2), K121160 (d2), K121434 (d2), K121459 (d2), K123510 (d2), K132831 (d2), K132951 (d2), K140253 (d2), K140998 (d2), K130885 (d2), K132119 (d2), K050263 (d2), K143311 (d2), K072237 (d3), K082427 (d3), K091114 (d3), K103274 (d3), K092519 (d3), K101347 (d3), K123938 (d3), K041112 (d4), K053042 (d4) — cited as predicate by K163211, K163234, K163294, K163312, K170396, K170840, K173592, K173600, K181322, K181433, K181613, K182129, K191050, K192496, K193324, K202014, K250443

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