Medical device recalls High risk

Hamilton Medical, Inc. recalls Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

Recall date
July 26, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2526-2023
FDA classification
Class I
Brand / firm
Hamilton Medical, Inc.
Sold / distributed
Distribution US nationwide, including Puerto Rico. OUS: Not provided

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

Get recall alerts

Free email alert whenever Hamilton Medical, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Hamilton Medical, Inc.