Z-1429-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2023
- Initiation Date
- March 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103
Product Description
HAMILTON-C6, REF: 160021
Reason for Recall
Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.
Distribution Pattern
US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
Code Information
Software Version: 1.2.1, UDI-DI: 07630002808590