Z-2795-2018Class II

Hamilton-C1 Ventilator Unit

Name: Z-2795-2018 Hamilton-C1 Ventilator Unit
Creator: Hamilton Medical AG
Published: 2018-03-09
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2018-03-09 / Terminated / root cause: manufacturing process

FDA source

Hamilton Medical AG began a recall of Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics... on 2018-03-09. FDA classified it as Class II and gives the reason as "An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2795-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-09
Posted: 2018-08-14
Terminated: 2019-03-18
Recalling firm: Hamilton Medical AG
Product: Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hamilton Medical notified customers on about 03/09/2018 via letter. Instructions included that a Hamilton Medical Field Service Representative will be in contact with each customer to schedule the correction. Questions or concerns can be directed to Hamilton Technical Support at 1-800-426-6331, option #2.
Quantity in commerce: 16 devices
Distribution: US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI. Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.
Product codes and lots: Serial Number: 12244, 12246, 12338, 12343, 12344, 12345, 12351, 12352, 12355, 12370, 12380, 12382, 12383, 12412, 12426, 12432

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2795-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2795-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-13
Z-2796-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-13

Product code CBK

K140939Class IIHamilton-T1,hamilton-C1Hamilton Medical AG / cleared 2015-09-02

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)