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Open, Classified

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

FDA Recall Z-2525-2023 · Posted 2023-09-20

Recalling FirmHamilton Medical, Inc.
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2023-07-26
Product Quantity164 units

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.

Firm Action

On July 26, 2023, Hamilton Medical issued Urgent Medical Device Correction via E-Mail. Hamilton Medical asked consignees to take the following actions 1. Check for affected devices in your facility. Get in contact with your local distribution partner and get the devices serviced with high priority. 2. Please sign the enclosed/attached sheet to confirm that, as an End- Customer, you have received and duly noted this Medical Device Correction.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution US nationwide, including Puerto Rico. OUS: Not provided

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181216HAMILTON-T1, HAMILTON-C1Hamilton Medical AG · 2019-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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