Z-0741-2013Class I

HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to...

Name: Z-0741-2013 HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to...
Creator: Hamilton Medical Inc
Published: 2012-12-19
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2012-12-19 / Terminated / root cause: software

FDA source

Hamilton Medical Inc began a recall of HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to... on 2012-12-19. FDA classified it as Class I and gives the reason as "Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0741-2013
Classification: Class I
Status: Terminated
Initiated: 2012-12-19
Posted: 2013-01-31
Terminated: 2014-04-22
Recalling firm: Hamilton Medical AG
Product: HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
Root cause tag: software
FDA root cause: Software design
Action: Hamilton sent a Field Safety alert letter dated January 11, 2013 to all customers. The letter identified the affected product, explained the potential problem and a included Medical Device Safety Alert and Corrective Action document. Hamilton is working on a new software version for this issue. Customers are asked to update their operator manual with the update oxygen consumption formula page which provided revised information for calculating oxygen capacity. When the new software is available, Hamilton will provide loaner devices to each location while their unit is being upgraded. Questions should be addressed to Hamilton Medical at 800-426-6331 ext 215
Quantity in commerce: 97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Distribution: US Nationwide Distribution including the country of Switzerland.
Product codes and lots: Software Versions 1.1.2 and below; Part numbers 161005, 161006.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0741-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0741-2013	Class I	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-31

Product code CBK

K120670Class IIHamilton-T1Hamilton Medical AG / cleared 2012-04-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)