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Citadel

Model CX811A3F3AMAB0 · Arjohuntleigh AB · DI 05055982755764

IOQ — Bed, Flotation Therapy, Powered · Class II · 21 CFR 890.5170

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 (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (121)

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: 107 · Injury: 13 · Death: 1

51015202019-03: 2 reports for this device; peer average 2/device2019-05: 1 reports for this device; peer average 1/device2019-09: 1 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 1 reports for this device; peer average 1/device2019-12: 3 reports for this device; peer average 3/device2020-02: 3 reports for this device; peer average 2/device2020-03: 1 reports for this device; peer average 1/device2020-04: 1 reports for this device; peer average 1/device2020-06: 1 reports for this device; peer average 1/device2020-07: 1 reports for this device; peer average 1/device2020-11: 1 reports for this device; peer average 1/device2021-02: 1 reports for this device; peer average 2/device2021-03: 1 reports for this device; peer average 1.33/device2021-04: 0 reports for this device; peer average 3.25/device2021-05: 0 reports for this device; peer average 2.33/device2021-06: 0 reports for this device; peer average 10/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 2/device2021-09: 1 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 1.5/device2021-11: 0 reports for this device; peer average 4/device2021-12: 3 reports for this device; peer average 5.5/device2022-01: 3 reports for this device; peer average 4/device2022-02: 0 reports for this device; peer average 4.33/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 1 reports for this device; peer average 2.75/device2022-05: 0 reports for this device; peer average 2/device2022-06: 1 reports for this device; peer average 3.67/device2022-07: 2 reports for this device; peer average 2.25/device2022-08: 1 reports for this device; peer average 2.2/device2022-09: 1 reports for this device; peer average 2.2/device2022-10: 1 reports for this device; peer average 3.25/device2022-11: 2 reports for this device; peer average 3.67/device2022-12: 0 reports for this device; peer average 2/device2023-01: 1 reports for this device; peer average 2.25/device2023-02: 2 reports for this device; peer average 2.4/device2023-03: 2 reports for this device; peer average 6.6/device2023-04: 4 reports for this device; peer average 8/device2023-05: 1 reports for this device; peer average 8/device2023-06: 1 reports for this device; peer average 13.25/device2023-07: 4 reports for this device; peer average 7.2/device2023-08: 1 reports for this device; peer average 8.67/device2023-09: 0 reports for this device; peer average 6.75/device2023-10: 3 reports for this device; peer average 5/device2023-11: 2 reports for this device; peer average 8.5/device2023-12: 0 reports for this device; peer average 5/device2024-01: 1 reports for this device; peer average 9/device2024-02: 1 reports for this device; peer average 2.33/device2024-03: 2 reports for this device; peer average 7.6/device2024-04: 2 reports for this device; peer average 4.5/device2024-05: 1 reports for this device; peer average 5.13/device2024-06: 2 reports for this device; peer average 6.11/device2024-07: 4 reports for this device; peer average 7.17/device2024-08: 1 reports for this device; peer average 6.13/device2024-09: 3 reports for this device; peer average 5.14/device2024-10: 2 reports for this device; peer average 5/device2024-11: 1 reports for this device; peer average 14.89/device2024-12: 2 reports for this device; peer average 7.33/device2025-01: 3 reports for this device; peer average 12/device2025-02: 2 reports for this device; peer average 9.85/device2025-03: 5 reports for this device; peer average 9.55/device2025-04: 3 reports for this device; peer average 9.44/device2025-05: 3 reports for this device; peer average 8/device2025-06: 2 reports for this device; peer average 11.38/device2025-07: 3 reports for this device; peer average 10.25/device2025-08: 1 reports for this device; peer average 7.75/device2025-09: 0 reports for this device; peer average 9.67/device2025-10: 1 reports for this device; peer average 7.7/device2025-11: 4 reports for this device; peer average 12.82/device2025-12: 2 reports for this device; peer average 20/device2026-01: 2 reports for this device; peer average 9.92/device2026-02: 1 reports for this device; peer average 18.33/device2026-03: 3 reports for this device; peer average 19.1/device2026-04: 1 reports for this device; peer average 13.36/device2026-05: 3 reports for this device; peer average 14.08/device2026-06: 5 reports for this device; peer average 16.11/device0305091011120203040607110203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0322
2019-0511
2019-0911
2019-1001
2019-1111
2019-1233
2020-0232
2020-0311
2020-0411
2020-0611
2020-0711
2020-1111
2021-0212
2021-0311.33
2021-0403.25
2021-0502.33
2021-06010
2021-0703
2021-0802
2021-0911.5
2021-1001.5
2021-1104
2021-1235.5
2022-0134
2022-0204.33
2022-0301.5
2022-0412.75
2022-0502
2022-0613.67
2022-0722.25
2022-0812.2
2022-0912.2
2022-1013.25
2022-1123.67
2022-1202
2023-0112.25
2023-0222.4
2023-0326.6
2023-0448
2023-0518
2023-06113.25
2023-0747.2
2023-0818.67
2023-0906.75
2023-1035
2023-1128.5
2023-1205
2024-0119
2024-0212.33
2024-0327.6
2024-0424.5
2024-0515.13
2024-0626.11
2024-0747.17
2024-0816.13
2024-0935.14
2024-1025
2024-11114.89
2024-1227.33
2025-01312
2025-0229.85
2025-0359.55
2025-0439.44
2025-0538
2025-06211.38
2025-07310.25
2025-0817.75
2025-0909.67
2025-1017.7
2025-11412.82
2025-12220
2026-0129.92
2026-02118.33
2026-03319.1
2026-04113.36
2026-05314.08
2026-06516.11
This device (reports/month)Average device in IOQ (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