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
950001950004
- 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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