Z-1185-2012

HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and...

Name: Z-1185-2012 HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and...
Creator: Hamilton Medical Inc
Published: 2012-02-06
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2012-02-06 / Terminated / root cause: software

FDA source

Hamilton Medical Inc began a recall of HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV... on 2012-02-06. The reason FDA records is "Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions". 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-1185-2012
Status: Terminated
Initiated: 2012-02-06
Posted: 2012-03-07
Terminated: 2013-10-23
Recalling firm: Hamilton Medical AG
Product: HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. Product Usage: Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions.
Root cause tag: software
FDA root cause: Software design
Action: Hamilton Medical sent a Medical Device Safety Alert and Correction Action letter dated February 17, 2011 to all affected customers via a traceable method. The letter identified the affected product, problem and immediate actions required by operators, distributor and manufacturer. The letter states that a Hamilton Medical Account manager will contact customers to schedule a convenient time for the Technical Support Department to install the software update. Questions or concerns may be directed to Technical Support Manager at 800-426-6331, Ext 125.
Quantity in commerce: 456 devices in US.
Distribution: (USA) Nationwide Distribution including the states of: CA, CO, FL, GA, MA, MI, MO, NC, NV, NY, PA, TN, TX, VA and WV.
Product codes and lots: All Hamilton 5

Product code CBK

K103803Class IIHamilton-G5Hamilton Medical AG / cleared 2011-11-23

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)