Reported Nov 11, 2015 · Terminated
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is…
Hamilton Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hamilton Medical, Inc. · 4990 Energy Way · Reno, NV · 89502-4123
Is this the product you have?
- HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31
- AnesthesiologyThe HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
- Lot codes and dates
- software versions between V2.00 and V2.31
- Ventilator catalog number1590001
- Software catalog number159700
- Serial numbers
1,043 of 1,043 codes
123112331234123510141296159315941595162616281629163116321633163416371693169718621863202124112412241324142416241724182591259225932594259526812683268626872689277627772778277927802781278427852786278727892790279327942798280328872947294829512952
- Amount recalled
- 1128
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
Using this product could cause serious injury, illness or death — stop using it now.
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