Z-1429-2023 Class II Ongoing
FDA device recall Z-1429-2023 was initiated by Hamilton Medical AG on March 14, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 103.
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