CLASS II ONGOING Device recall · Reported 3 May 2023 · FDA Enforcement Report

Hamilton-C6, REF recalled by Hamilton Medical AG

Hamilton Medical is recalling Hamilton-C6, REF: 160021, distributed nationwide in the US. The recall was initiated on 14 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Version: 1.2.1, UDI-DI: 07630002808590

Quantity recalled103

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1429-2023
FDA event ID: 91925
Recalling firm: Hamilton Medical, Bonaduz, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 14 Mar 2023
FDA classified: 25 Apr 2023
Reported: 3 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

14 Mar 2023	Recall initiated by company
25 Apr 2023	Classified by FDA	+42 days
3 May 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

HAMILTON-C6, REF: 160021

Where it was distributed

US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.

Nationwide California Florida Georgia Idaho Kansas Massachusetts Missouri North Carolina New Mexico Nevada New York Pennsylvania South Carolina Virginia Wyoming

Questions about this recall

Why was it recalled?

Which lots are affected?

Software Version: 1.2.1, UDI-DI: 07630002808590

Where was it sold?

US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Hamilton Medical

All 34

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	IntelliCuff, Portable automatic cuff pressure controller recalled	Hamilton Medical	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS I	Hamilton C6 recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide
6 Aug 2025Device	CLASS I	Breathing circuit set, coaxial, 1.80 m, with flow sensor recalled	Hamilton Medical	Device Malfunction	Nationwide
26 Jun 2024Device	CLASS I	Ventilator Hamilton-C6, PN recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide

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