Z-1371-2018Class II

Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally...

Name: Z-1371-2018 Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally...
Creator: Hamilton Medical AG
Published: 2018-03-12
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2018-03-12 / Open, Classified

FDA source

Hamilton Medical AG began a recall of Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital on 2018-03-12. FDA classified it as Class II and gives the reason as "After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1371-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-03-12
Posted: 2018-04-12
Recalling firm: Hamilton Medical AG
Product: Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
FDA root cause: Other
Action: Customers were notified via letter on about 03/12/2018. The letter identified the affected device and described the issue. Instructions for medical facilities are to inspect the batteries for the battery manufacturing date and replace any batteries that are found to be in use for two years or more. Instructions for determining the battery manufacturing date are included in the Medical Device Field Safety Corrective Action Update attached to the letter. Questions or concerns can be directed to Bret Everett at 817-909-0308 or Hamilton Technical Support at 1-800-426-6331.
Quantity in commerce: 739 units total
Distribution: 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.
Product codes and lots: Product No. 160001 All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1371-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1371-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-04-18	2018-04-12
Z-1372-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-04-18	2018-04-12

Product code CBK

K121225Class IIHamilton-C2Hamilton Medical AG / cleared 2012-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)