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HexaLux

Model HexaLux Ceiling Mount · STERIS CORPORATION · DI 00724995244286

KZF — Device, Medical Examination, Ac Powered · Class I · 21 CFR 880.6320

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 (18)

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: 18

358102019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 4/device2020-03: 0 reports for this device; peer average 1.1/device2020-05: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 10/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-06: 1 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 3/device2023-11: 1 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-01: 1 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 1 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 2/device2025-07: 3 reports for this device; peer average 1.75/device2025-08: 3 reports for this device; peer average 1.75/device2025-10: 2 reports for this device; peer average 1.33/device2025-12: 3 reports for this device; peer average 1.75/device2026-03: 0 reports for this device; peer average 8/device2026-04: 3 reports for this device; peer average 1.8/device0304050708091112030507091002030406081012010507080911030405060809101112010203040502070810120304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0301
2019-0401
2019-0502
2019-0702
2019-0802
2019-0903
2019-1101
2019-1204
2020-0301.1
2020-0501
2020-0702
2020-0901
2020-1001
2021-0202
2021-0302
2021-0401
2021-0602
2021-0803
2021-1003
2021-1201
2022-0101
2022-0501
2022-07010
2022-0801
2022-0901
2022-1101
2023-0302
2023-0401
2023-0501
2023-0611
2023-0801
2023-0902
2023-1003
2023-1111
2023-1201
2024-0111
2024-0201
2024-0301
2024-0411
2024-0501
2025-0202
2025-0731.75
2025-0831.75
2025-1021.33
2025-1231.75
2026-0308
2026-0431.8
This device (reports/month)Average device in KZF (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STERIS CORPORATION

  • Warning Letter 2015-02-20 Key Surgical LLC
  • Warning Letter 2014-05-22 Isomedix Operations, Inc.
  • Warning Letter 2012-05-29 Albert Browne Ltd.
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2010-09-27 Isomedix Operations, Inc.
  • Injunction 2010-04-20 Steris Corporation
  • Injunction 2010-04-20 Steris Corporation
  • Warning Letter 2009-07-31 Medivators Inc
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-03 Isomedix Operations Inc. · 0 citations
  • NAI 2026-03-12 Isomedix Operations Inc · 0 citations
  • VAI 2026-02-26 Steris S.p.A. · 1 citations
  • VAI 2026-02-12 Synergy Health Ede BV · 2 citations
  • NAI 2026-02-12 Synergy Health Marseille · 0 citations
  • OAI 2025-12-12 Black Diamond Video Inc. · 3 citations
  • VAI 2025-08-01 STERIS Laboratories, Inc. · 2 citations
  • NAI 2025-06-18 Isomedix Operations Inc. · 0 citations
  • NAI 2025-06-17 Isomedix Operations Inc · 0 citations
  • NAI 2025-06-05 Isomedix Operations, Inc. · 0 citations
  • NAI 2025-04-01 Steris Corporation · 0 citations
  • NAI 2025-02-21 Isomedix Operations Inc. · 0 citations
  • NAI 2025-01-23 Synergy Health Allershausen GmbH · 0 citations
  • VAI 2024-12-12 Isomedix Operations, Inc · 0 citations
  • NAI 2024-12-05 Steris (Synergy Health Ede BV) · 0 citations
  • VAI 2024-11-21 Steris Applied Sterilization Technologies ULC · 2 citations
  • NAI 2024-09-23 Isomedix Operations, Inc. · 0 citations
  • NAI 2024-09-19 Isomedix Operations, Inc. · 0 citations