Z-2057-2015Class II

Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002...

Name: Z-2057-2015 Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002...
Creator: Hamilton Medical, Inc.
Published: 2015-03-24
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2015-03-24 / Terminated / root cause: design

FDA source

Hamilton Medical, Inc. began a recall of Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and... on 2015-03-24. FDA classified it as Class II and gives the reason as "Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device". 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-2057-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-24
Posted: 2015-07-10
Terminated: 2015-12-23
Recalling firm: Hamilton Medical AG
Product: Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
Root cause tag: design
FDA root cause: Device Design
Action: *** Please note *** This is not a new recall. An error occurred, and this recall was originally classified as a class I on July 10, 2015. No further action is required. Hamilton Medical AG notified their customers with a letter dated February 19, 2015 and had a fix (SW 2.42) that was available as of February 20th 2015. Hamilton Medical proceeded to send out notification letters the 24th of March 2015 once they compiled the complete and validated list of customers that had the affected software. Customers with questions were instructed to call 800-426-6331, ext.215.
Quantity in commerce: 248
Distribution: Nationwide Distribution
Product codes and lots: Software version 2.20 and 2.41,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2057-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2057-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24

Product code CBK

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)