Recall Z-2525-2023— Hamilton Medical, Inc.

Name: FDA recall Z-2525-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-26

Class I · Ongoing

Class I FDA medical device recall by Hamilton Medical, Inc., initiated 2023-07-26. It names one FDA 510(k) clearance: K181216. Product: Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator. Reason: 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..

Recalling firm: Hamilton Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-07-26
Firm location: Reno, NV, United States

510(k) clearances named in this recall

1 on FDA's record

K181216 — HAMILTON-T1, HAMILTON-C1Hamilton Medical AG·cleared 2019-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.