Hamilton Medical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0170-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 26, 2013

Date Posted: November 13, 2013

Recall Number: Z-0170-2014

Event ID: 66408

Reason for Recall:

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

Status: Terminated

Product Quantity: 316 devices distributed in the US.

Code Information:

Hamilton-C2; Serial numbers from 1000-7100.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated