Hamilton Medical, Inc. recalls Hamilton-MR1, REF: 161010, Intensive Care Ventilator

Recall date

July 26, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2528-2023

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-MR1, REF: 161010, Intensive Care Ventilator