Reported Nov 13, 2013 · Terminated

HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by…

Hamilton Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hamilton Medical, Inc. · 4990 Energy Way · Reno, NV · 89502-4123

Is this the product you have?

  • HAMILTON-C2 VentilatorManufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration
  • Intended areas of useIn the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital
Lot codes and dates
    • Hamilton-C2
    • Serial numbers from 1000-7100
Amount recalled
316 devices distributed in the US.

Where it was sold

Why it was recalled

Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 29, 2018 · Data as of Sep 19, 6:06 PM UTC

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