Reported Aug 2, 2023 · Ongoing
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support…
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 T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Lot codes and dates
- ModelHAMILTON-T1
- REF161006 1610060 161009 1610090
- UDI-DI Code07630002801850 07630002813532 07630002806091 07630002813549
- Serial Numbers
2,293 of 2,293 codes
305730583063307030773081308530893093311231153119312131243126312731293131313231333136313831403168316931853191319331953199320032353236324132433245324732493250325832593263327532803299330733093311331233133317332033403574357635773579358036043605
- Puerto Rico Serial Numbers
4829553311699151981749017514183101853324411500778501862502935504094504981505215505491505509506149506204507335508346509160509296509942509943509946509998
- Amount recalled
- 2319 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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