Hamilton-C2 Ventilator recalled by Hamilton Medical

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

HAMILTON-C2 Ventilator: Manufactured 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 use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.

Where it was distributed

Nationwide distribution: USA including Puerto Rico and the states of IL, MT, IN, ND, AZ, MT, KY, NC, OH, MA, MO, VA, CA, NV, TX, WA, NY, GA, SC,MN, WY, PA, ND, UT, NE, CO and MI.

Nationwide ArizonaCaliforniaColoradoGeorgiaIllinoisIndianaKentuckyMassachusettsMichiganMinnesotaMissouriMontanaNorth CarolinaNorth DakotaNebraskaNevadaNew YorkOhioPennsylvaniaPuerto Rico