Z-1928-2011

Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software...

Name: Z-1928-2011 Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software...
Creator: Hamilton Medical Inc
Published: 2011-02-16
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2011-02-16 / Terminated / root cause: software

FDA source

Hamilton Medical Inc began a recall of Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software... on 2011-02-16. The reason FDA records is "The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator". 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-1928-2011
Status: Terminated
Initiated: 2011-02-16
Posted: 2011-04-08
Terminated: 2012-03-21
Recalling firm: Hamilton Medical AG
Product: Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical Intended for use in the hospital and institutional environment where healthcare professionals provide patient care.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator.
Root cause tag: software
FDA root cause: Software design
Action: A Medical device Safety Alert and Corrective Action along with a cover letter, was sent to all locations on February 16, 2011. The letter identified the affected product along with the reason for recall. The letter states that operators deactivate the "high tidal volume" alarm as described in appendix K.4 of the operator's manual until the ventilator is upgraded with a corrected software. Distributors will upgrade the affected devices with the corrected software as soon as possible. Questions can be directed to 800-426-6331, ext 215.
Quantity in commerce: 97 units
Distribution: Nationwide Distribution -- MA, FL, GA, NC, MI, NC, MO, TX, and WV.
Product codes and lots: Software version V2.00x and Neonatal Option or V2.01x and Neonatal software

Product code CBK

K081521Class IIModification to Hamilton-G5Hamilton Medical AG / cleared 2008-09-25

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)