Use cautionMedical device recall · FDA · Published March 14, 2023
Hamilton C6 Ventilator Software Error: Safety Ventilation Not Monitored
Hamilton Medical recalls C6 ventilators with software version 1.2.1 due to safety ventilation mode not monitoring patient inputs, risking undetected issues during certain settings.
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.
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Contact the company
📍Recalling firmHamilton Medical AGVia Crusch 8 · Bonaduz, Switzerland
“Hamilton C6 Ventilator Software Error: Safety Ventilation Not Monitored.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58756-hamilton-c6-ventilator-software-error-safety-ventilation-not-monitored. Based on FDA recall #Z-1429-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1429-2023%22&limit=1).
The FDA announced on March 14, 2023, that Hamilton Medical AG is recalling the HAMILTON-C6 ventilator (REF: 160021) due to a software error. The hazard involves ventilation continuing in 'safety ventilation' mode with patient inputs not monitored under specific conditions.
How to tell if you have it
Brand: Hamilton Medical
Product: HAMILTON-C6
REF: 160021
Software Version: 1.2.1
UDI-DI: 07630002808590
The hazard
A software error causes the ventilator to continue in 'safety ventilation' mode with audible and visible alarms while patient inputs are not monitored. This occurs when a mode change to an adaptive mode coincides with the controller and/or humidifier being connected and operational.
Context
GovInfoNow's records show Hamilton Medical AG has 11 other recalls on record since March 9, 2018. Other recent recalls of similar products include a Breathing Circuit Sets recall dated May 29, 2026, and an IntelliCuff Recall dated May 22, 2026. Other recent recalls of similar products include a Breathing Circuit Recall dated June 26, 2025, a Getinge SERVO-U/N Ventilator Sensor Module Recall dated June 30, 2026, and a Philips Respironics Trilogy EV300 Ventilator Software Update Risk dated March 2, 2026.
How to tell if you have this one
Check for the model name 'Hamilton C6' and software version 1.2.1. The unique device identifier (UDI-DI) 07630002808590 is also associated with this recall.
Brand
Hamilton Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Hamilton C6 ventilator; if it is 1.2.1, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Idaho, Kansas, Massachusetts, Missouri, Nevada, New Mexico, New York, North Carolina, Pennsylvania, South Carolina, Virginia, Wyoming.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1429-2023 (March 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1429-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.