Agency classClass IIOur severity:High FDA (Devices)·Z-1429-2023·Announced 2023-05-03

Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring

The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a FDA Class II medical device recall involving a critical ventilator function (patient input monitoring) with potential for patient harm. No illnesses or injuries have been reported, and the hazard remains theoretical. This qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.

Plain-English summary

Hamilton Medical AG is recalling 103 HAMILTON-C6 ventilators (Software Version 1.2.1, UDI-DI: 07630002808590) due to a software error that affects patient safety monitoring during critical mode transitions.

When the ventilator switches to certain adaptive ventilation modes (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, or SIMV+) and a controller or humidifier is connected and operational, the device enters "safety ventilation" mode but stops monitoring patient inputs. The device will emit an audible and visible alarm, but cannot respond to patient needs during this critical condition.

Affected units have been distributed nationwide across California, Massachusetts, Idaho, North Carolina, Georgia, Florida, Nevada, Pennsylvania, Missouri, Kansas, South Carolina, New York, New Mexico, Wyoming, and Virginia.

Patients and healthcare providers using affected HAMILTON-C6 ventilators should immediately review the safety alert from Hamilton Medical AG and contact the manufacturer or their equipment provider for guidance on software updates or device replacement.

The recalled product

Product: HAMILTON-C6, REF: 160021
Manufacturer: Hamilton Medical AG
Category: Medical Device — Ventilator / Respiratory Equipment
Hazard: software-error
monitoring-failure
ventilation-failure
Affected units: 103

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Software Version: 1.2.1
UDI-DI: 07630002808590

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Same manufacturer · Hamilton Medical AG

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