FDA-Device2023-09-27Class I

Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator

Hamilton Medical, Inc.
Hazard

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

Sold states
Distribution US nationwide, including Puerto Rico. OUS: Not provided
Affected count
164 units
Manufactured in
4655 Aircenter Cir, Reno, NV, United States
Products
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2525-2023

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