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Recall Observatory FDA recall evidence

Device product

HAMILTON-H900 Humidifier, Models: 950001, 950004

Z-1385-2022

January 05, 2021

Class III

Product summary

Firm
Hamilton Medical AG
Event
Event 90460
Status
Completed
Classification
Class III
Quantity
203
Official record key
device-enforcement:Z-1385-2022

Official wording

Reason: When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.

Code information: UDI:07630002801546. All devices with software version 1.10c

Distribution pattern: US: WI, FL, CA, NV, PA, TX, PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.