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

Recalled November 13, 2013 · FDA recall Z-0170-2014 · Hamilton Medical

Hazard

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

Units

316 devices distributed in the US.

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Hamilton Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →