Z-1385-2022 Class III
FDA device recall Z-1385-2022 was initiated by Hamilton Medical AG on January 5, 2021 and is designated Class III. Reason for recall: 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 w… Affected quantity: 203.
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2022
- Initiation Date
- January 5, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 203
Product Description
HAMILTON-H900 Humidifier, Models: 950001, 950004
Reason for Recall
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.
Distribution Pattern
US: WI, FL, CA, NV, PA, TX, PA
Code Information
UDI:07630002801546. All devices with software version 1.10c