Z-0170-2014Class II

HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and...

Name: Z-0170-2014 HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and...
Creator: Hamilton Medical, Inc.
Published: 2013-09-26
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2013-09-26 / Terminated / root cause: design

FDA source

Hamilton Medical, Inc. began a recall of HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The... on 2013-09-26. FDA classified it as Class II and gives the reason as "Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0170-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-26
Posted: 2013-11-06
Terminated: 2018-03-29
Recalling firm: Hamilton Medical AG
Product: HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.
Root cause tag: design
FDA root cause: Device Design
Action: Hamilton Medical sent an Medical Device Safety Alert and Corrective Action letter dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The corrective action does not require any action by the operator. In the case of an alarm situation as described in the letter, users should follow the instruction for use (Section 8 - responding to alarms in the operator manual) and have the ventilator serviced by an authorized service technician. An addendum to the Operators Manual as a result of the field correction was provided to customers with the Safety Alert Letter. Manufacture will develop and provision a test protocol for the service tech which test the proper functioning of the loudspeaker during the annual service inspection. We appreciate your support in this matter and sincerely regret any inconveniences that this action may cause you. We consider this action as necessary to ensure that our customers receive only safe and effective products with high quality. Further questions please call (775) 426-6331 Ext. 210
Quantity in commerce: 316 devices distributed in the US.
Distribution: Nationwide distribution: USA including Puerto Rico and the states of IL, MT, IN, ND, AZ, MT, KY, NC, OH, MA, MO, VA, CA, NV, TX, WA, NY, GA, SC,MN, WY, PA, ND, UT, NE, CO and MI.
Product codes and lots: Hamilton-C2; Serial numbers from 1000-7100.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0170-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)