CLASS II Device recall · Reported 5 Aug 2015 · FDA Enforcement Report

Hamilton-G5 Ventilators recalled by Hamilton Medical

Hamilton Medical is recalling Hamilton-G5 Ventilators, distributed nationwide in the US. The recall was initiated on 24 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware version 2.20 and 2.41,

Quantity recalled248

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2057-2015
FDA event ID: 71234
Recalling firm: Hamilton Medical, Reno, NV
Classification: Class II
Status: Terminated
Recall initiated: 24 Mar 2015
FDA classified: 24 Jul 2015
Reported: 5 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

24 Mar 2015	Recall initiated by company
24 Jul 2015	Classified by FDA	+122 days
5 Aug 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Software version 2.20 and 2.41,

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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26 Jun 2024Device	CLASS I	Ventilator Hamilton-C6, PN recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide

Other CPAP & Ventilators recalls

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Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled	CooperSurgical	Other	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled	CooperSurgical	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide