FDA Device recall Z-1429-2023
HAMILTON-C6, REF: 160021
- FDA Device
- Class II
- ongoing
- Published 2023-05-03
On 2023-05-03 the FDA classified a Class II recall of HAMILTON-C6, REF: 160021 by Hamilton Medical Ag, citing 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 fo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1429-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-14 |
| Published | 2023-05-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hamilton Medical Ag |
| Distribution | US |
Product
HAMILTON-C6, REF: 160021
Reason
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.
Identifiers
| code_info | Software Version: 1.2.1, UDI-DI: 07630002808590 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1429-2023%22
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