CLASS II ONGOING Device recall · Reported 18 Apr 2018 · FDA Enforcement Report

Hamilton-C3 Ventilator Unit Intended to provide ventilator recalled

Hamilton Medical is recalling Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and, distributed in 30 states. The recall was initiated on 12 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct No. 160005 All Serial Numbers

Quantity recalled739 units total

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-1372-2018
FDA event ID: 78599
Recalling firm: Hamilton Medical, Bonaduz
Classification: Class II
Status: Ongoing
Recall initiated: 12 Mar 2018
FDA classified: 12 Apr 2018
Reported: 18 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

12 Mar 2018	Recall initiated by company
12 Apr 2018	Classified by FDA	+31 days
18 Apr 2018	Published in enforcement report	+6 days

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

Reason for recall

After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.

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-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

Where it was distributed

Worldwide Distribution -- USA, including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MN, MO, MT, NC, ND, NE, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Austria, Azerbaijan, Bangladesh, Belarus, Belgian, Bolivia, Brazil, Bulgaria, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechia, Denmark, Dominican. Rep., Ecuador, Egypt, El Salvador, Estland, Finland, France, Gabon, Germany, Greece, Guatemala, Holland, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mauritius, Macedonia, Mexico, Mongolia, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Scotland, Serbia, Seychelles, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, Sudan, Suriname, Sweden, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, UK , Ukraine, Uruguay, Venezuela, Vietnam, and Yemen.

Arizona California Colorado Florida Georgia Hawaii Illinois Indiana Kentucky Massachusetts Michigan Minnesota Missouri Montana North Carolina North Dakota Nebraska Nevada Ohio Oklahoma

Questions about this recall

Why was it recalled?

After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.

Which lots are affected?

Product No. 160005 All Serial Numbers

Where was it sold?

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.

Other products in this recall event

1 other product · FDA event 78599

This product is part of a recall event; the main page for the event is Hamilton-C2 Ventilator Unit Intended to provide ventilator recalled.

Reported	Class	Recall	Company	Reason	Where
18 Apr 2018	CLASS II	Hamilton-C2 Ventilator Unit Intended to provide ventilator recalled	Hamilton Medical	Device Malfunction	30 states

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