Reported Aug 2, 2023 · Ongoing
HAMILTON C1 Ventilator REF 161001 1610010 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 C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Lot codes and dates
- ModelHAMILTON-C1
- REF161001 1610010
- UDI-DI Code07630002800747
- Serial Numbers
673 of 673 codes
600660236024620362646267631863236586707570787087728378677869787078747878788779027923793279358259827784318444846387498940894389519216922893349392940594099463946795089571957795849591959796229629963496529653965496569664968597049726972897429742
- Puerto Rico Serial Numbers
9722126291710922796227972279822799228002280122802228032280425530232602798219896
- Amount recalled
- 689 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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