HAMILTON-H900 Humidifier recall
HAMILTON-H900 Humidifier, Models: 950001, 950004
Why was HAMILTON-H900 Humidifier 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI:07630002801546. All devices with software version 1.10c
- Product
- HAMILTON-H900 Humidifier, Models: 950001, 950004
- Recalling firm
- Hamilton Medical AG
- Quantity
- 203
- Distribution
- US: WI, FL, CA, NV, PA, TX, PA
- Recall date
- July 20, 2022
- Classification
- Class III
- Status
- Completed
- Agency
- FDA (device)