Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Nimbus 4

ArjoHuntleigh AB

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 (15)

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: 13 · Death: 2

12232022-09: 2 reports for this device2022-11: 1 reports for this device2023-05: 1 reports for this device2023-06: 1 reports for this device2024-10: 1 reports for this device2025-04: 1 reports for this device2025-05: 3 reports for this device2025-08: 2 reports for this device2025-09: 1 reports for this device2025-10: 1 reports for this device2025-11: 1 reports for this device0911050610040508091011
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-092—
2022-111—
2023-051—
2023-061—
2024-101—
2025-041—
2025-053—
2025-082—
2025-091—
2025-101—
2025-111—
This device (reports/month)Average device in its product code (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