Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2525-2023 — Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator

U.S. FDA — Device Enforcement · United States · 2023-07-26 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2525-2023
Date of alert
2023-07-26
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Hamilton Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07630002800747
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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