Reported Aug 2, 2023 · Ongoing
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and…
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. · 4655 Aircenter Cir · Reno, NV · 89502-5948
Is this the product you have?
- HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Lot codes and dates
- ModelHAMILTON-C3
- REF 160005 UDI-DI Code07630002801881
- Serial Numbers
483 of 483 codes
100110031004100610081009101010111012101410191028103010321042112311741187119211981201120212061207121912201221122412251229123212331259126112641266145814591461146414651509151015111512151315141515151615171528152915301531153415361584159215971598
- Puerto Rico Serial Numbers
218 of 218 codes
108616501655235723572366236623692369237123712372237323732374237423752375249124942509251025112513251525162517251825192520252125232524252525262527252825292530253125322533253425352536253725382539256025622564256525662734287528773861440745134516
- Amount recalled
- 701 systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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