RecallRadar

FDA Device recall Z-2057-2015

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

On 2015-08-05 the FDA classified a Class II recall of Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002 by Hamilton Medical, citing 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 devi….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2057-2015
ClassificationClass II
Statusterminated
Initiated2015-03-24
Published2015-08-05
Last updated2026-09-13 11:53 UTC
CompanyHamilton Medical
DistributionUS

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.

Reason

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.

Identifiers

code_infoSoftware version 2.20 and 2.41,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2057-2015%22

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