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Citadel Plus

Model FX811B3B4AMABB · Arjohuntleigh AB · DI 05055982756532

FNL — Bed, Ac-Powered Adjustable Hospital · Class II · 21 CFR 880.5100

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (355)

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.

Malfunction: 334 · Injury: 20 · Death: 1

81624322019-01: 2 reports for this device; peer average 3.24/device2019-02: 2 reports for this device; peer average 2.11/device2019-03: 2 reports for this device; peer average 1.39/device2019-04: 1 reports for this device; peer average 3.6/device2019-05: 3 reports for this device; peer average 3.28/device2019-06: 1 reports for this device; peer average 1.14/device2019-07: 2 reports for this device; peer average 3.44/device2019-08: 0 reports for this device; peer average 1.13/device2019-09: 2 reports for this device; peer average 1.25/device2019-10: 1 reports for this device; peer average 3.74/device2019-11: 2 reports for this device; peer average 1.33/device2019-12: 2 reports for this device; peer average 1.58/device2020-01: 0 reports for this device; peer average 3.57/device2020-02: 1 reports for this device; peer average 1.93/device2020-03: 1 reports for this device; peer average 2/device2020-04: 1 reports for this device; peer average 2.79/device2020-05: 1 reports for this device; peer average 1/device2020-06: 1 reports for this device; peer average 1.42/device2020-07: 4 reports for this device; peer average 4.9/device2020-08: 0 reports for this device; peer average 1.04/device2020-09: 1 reports for this device; peer average 3.67/device2020-10: 1 reports for this device; peer average 3.5/device2020-11: 1 reports for this device; peer average 1.07/device2020-12: 4 reports for this device; peer average 2.32/device2021-01: 1 reports for this device; peer average 8.24/device2021-02: 2 reports for this device; peer average 1.6/device2021-03: 5 reports for this device; peer average 2.03/device2021-04: 2 reports for this device; peer average 3.06/device2021-05: 3 reports for this device; peer average 6/device2021-06: 0 reports for this device; peer average 1.76/device2021-07: 2 reports for this device; peer average 2.34/device2021-08: 3 reports for this device; peer average 2.8/device2021-09: 2 reports for this device; peer average 1.81/device2021-10: 4 reports for this device; peer average 3.88/device2021-11: 2 reports for this device; peer average 2.08/device2021-12: 2 reports for this device; peer average 3.45/device2022-01: 1 reports for this device; peer average 3.65/device2022-02: 6 reports for this device; peer average 1.68/device2022-03: 3 reports for this device; peer average 1.83/device2022-04: 5 reports for this device; peer average 2.47/device2022-05: 8 reports for this device; peer average 1.41/device2022-06: 3 reports for this device; peer average 2.89/device2022-07: 8 reports for this device; peer average 3.76/device2022-08: 0 reports for this device; peer average 1.26/device2022-09: 2 reports for this device; peer average 2.33/device2022-10: 3 reports for this device; peer average 3.03/device2022-11: 5 reports for this device; peer average 2.31/device2022-12: 5 reports for this device; peer average 3.79/device2023-01: 6 reports for this device; peer average 2.25/device2023-02: 5 reports for this device; peer average 1.47/device2023-03: 8 reports for this device; peer average 3.27/device2023-04: 5 reports for this device; peer average 5.09/device2023-05: 7 reports for this device; peer average 6.26/device2023-06: 8 reports for this device; peer average 3.73/device2023-07: 2 reports for this device; peer average 5.07/device2023-08: 4 reports for this device; peer average 7.5/device2023-09: 8 reports for this device; peer average 5.9/device2023-10: 5 reports for this device; peer average 3.76/device2023-11: 7 reports for this device; peer average 8.22/device2023-12: 2 reports for this device; peer average 8.71/device2024-01: 10 reports for this device; peer average 4.85/device2024-02: 3 reports for this device; peer average 2.5/device2024-03: 6 reports for this device; peer average 7.12/device2024-04: 10 reports for this device; peer average 5.81/device2024-05: 5 reports for this device; peer average 7.91/device2024-06: 5 reports for this device; peer average 9.73/device2024-07: 7 reports for this device; peer average 5.69/device2024-08: 3 reports for this device; peer average 7.77/device2024-09: 7 reports for this device; peer average 6.57/device2024-10: 3 reports for this device; peer average 4.57/device2024-11: 6 reports for this device; peer average 13.53/device2024-12: 4 reports for this device; peer average 7.73/device2025-01: 10 reports for this device; peer average 7.04/device2025-02: 8 reports for this device; peer average 5.57/device2025-03: 4 reports for this device; peer average 4.91/device2025-04: 5 reports for this device; peer average 6.62/device2025-05: 6 reports for this device; peer average 5.12/device2025-06: 13 reports for this device; peer average 9.32/device2025-07: 8 reports for this device; peer average 6.46/device2025-08: 6 reports for this device; peer average 4.02/device2025-09: 4 reports for this device; peer average 9.07/device2025-10: 4 reports for this device; peer average 3.32/device2025-11: 6 reports for this device; peer average 8.51/device2025-12: 3 reports for this device; peer average 8.49/device2026-01: 2 reports for this device; peer average 4.16/device2026-02: 5 reports for this device; peer average 5.84/device2026-03: 4 reports for this device; peer average 6.43/device2026-04: 6 reports for this device; peer average 7.36/device2026-05: 9 reports for this device; peer average 21.67/device2026-06: 3 reports for this device; peer average 32.34/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0123.24
2019-0222.11
2019-0321.39
2019-0413.6
2019-0533.28
2019-0611.14
2019-0723.44
2019-0801.13
2019-0921.25
2019-1013.74
2019-1121.33
2019-1221.58
2020-0103.57
2020-0211.93
2020-0312
2020-0412.79
2020-0511
2020-0611.42
2020-0744.9
2020-0801.04
2020-0913.67
2020-1013.5
2020-1111.07
2020-1242.32
2021-0118.24
2021-0221.6
2021-0352.03
2021-0423.06
2021-0536
2021-0601.76
2021-0722.34
2021-0832.8
2021-0921.81
2021-1043.88
2021-1122.08
2021-1223.45
2022-0113.65
2022-0261.68
2022-0331.83
2022-0452.47
2022-0581.41
2022-0632.89
2022-0783.76
2022-0801.26
2022-0922.33
2022-1033.03
2022-1152.31
2022-1253.79
2023-0162.25
2023-0251.47
2023-0383.27
2023-0455.09
2023-0576.26
2023-0683.73
2023-0725.07
2023-0847.5
2023-0985.9
2023-1053.76
2023-1178.22
2023-1228.71
2024-01104.85
2024-0232.5
2024-0367.12
2024-04105.81
2024-0557.91
2024-0659.73
2024-0775.69
2024-0837.77
2024-0976.57
2024-1034.57
2024-11613.53
2024-1247.73
2025-01107.04
2025-0285.57
2025-0344.91
2025-0456.62
2025-0565.12
2025-06139.32
2025-0786.46
2025-0864.02
2025-0949.07
2025-1043.32
2025-1168.51
2025-1238.49
2026-0124.16
2026-0255.84
2026-0346.43
2026-0467.36
2026-05921.67
2026-06332.34
This device (reports/month)Average device in FNL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Arjohuntleigh AB

  • NAI 2015-04-23 Arjo (Suzhou) Co., Ltd. · 0 citations
  • VAI 2014-03-20 ARJOHUNTLEIGH POLSKA Sp. z.o.o. · 3 citations
  • NAI 2013-02-07 ARJOHUNTLEIGH AB · 0 citations
  • NAI 2013-02-07 ARJOHUNTLEIGH AB · 0 citations
  • VAI 2012-09-06 Huntleigh Healthcare Ltd. · 0 citations
  • NAI 2011-11-24 Arjo (Suzhou) Co., Ltd. · 0 citations