Reported Jul 20, 2022 · Completed

HAMILTON-H900 Humidifier, Models: 950001, 950004

Hamilton Medical AG

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hamilton Medical AG · Via Crusch 8 · Bonaduz · N/A

Is this the product you have?

  • HAMILTON-H900 Humidifier
  • Models
    • 950001
    • 950004
Lot codes and dates
  • UDI07630002801546. All devices with software version 1.10c
Amount recalled
203

Where it was sold

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.