Recall Z-0170-2014 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical, Inc.
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; Dur
| Date | Nov 6, 2013 (initiated Sep 26, 2013) |
| Status | Terminated |
| Reason | Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded. |
| Root cause | Device Design |
| Action | Hamilton Medical sent an Medical Device Safety Alert and Corrective Action letter dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The corrective action does not require any action by the operator. In the case of an alarm situation as described in the letter, users should follow the instruction for use (Section 8 - responding to alarms in the operator manual) and have the ventilator serviced by an authorized service technician. An addendum to the Operators Manual as a result of the field corr |
| Quantity | 316 devices distributed in the US. |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121225 | HAMILTON-C2 Hamilton Medical AG, Nov 16, 2012 |